Abstract:
The present invention relates to antiperspirant deodorant cosmetic compositions comprising 2-methyl-5-cyclohexylpentanol, aluminum hydrochloride, hydroxypropylic starch phosphate, pantenol, and cosmetically acceptable adjuvants. The compositions exhibit deodorant and antiperspirant actions, sensorial emollient characteristics, and a protective film, and further provide a dermo-calming action on the skin for after-depilation use.

Description:
FIELD OF THE INVENTION 
       [0001]    The present invention relates to antiperspirant deodorant cosmetic compositions with dermo-calming action for after-depilation sensitized skin, applicable in the cosmetic, hygiene and personal-care industry. 
       BACKGROUND OF THE INVENTION 
       [0002]    Deodorants are intended for perfuming the body and, in general, they contain antimicrobial components, particularly antibacterial and antifungal, which eliminate bacteria and fungi that cause bad smell on the skin. Deodorants may be applied to armpits to perfume them and diminish the odors generated in this body region; however they do not prevent perspiration. 
         [0003]    Antiperspirants have the function of controlling the perspiration by inhibiting or reducing it, thus guaranteeing protection against sweat, besides having antimicrobial action, eliminating the microorganisms that cause bad smell. The antiperspirant action is due to the fact that this product acts by forming a blocking film that prevent sweat from coming out, without causing damage to one&#39;s health. 
         [0004]    It is known that depilation, be it by wax, laser or nippers, induces cutaneous irritation in determined persons and body regions. 
         [0005]    Among the measures which one should take with depilation are: non-exposure to direct sunshine, skin cleaning, use of light and loose clothes, as well as attention to deodorants, creams and body oils used after the depilatory procedure. For this reason, care with the skin has become essential, although cutaneous irritations still occur, even with such care. 
         [0006]    In this regard, the search for specific products for this purpose, particularly for deodorants that provide relief of irritation caused on the skin, i.e., sensitized by depilation, becomes critical. Also, in addition to deodorants that relieve irritation, it becomes essential to develop products that group deodorant characteristics to fight odor, antiperspirant for reducing sweat, and still that have a dermo-calming action on the skin. 
         [0007]    A few examples of prior-art documents related to the area of the present invention, particularly antiperspirant deodorants, are presented hereinafter. 
         [0008]    Patent application PI0924661-4, published on Nov. 21, 2012, in the name of Symrise AG, relates to ω-cycle-hexylalkan-1-ols, to the use of said compounds as antimicrobial agents for the treatment of odor on the body or for the preparation of an antimicrobial cosmetic or pharmaceutical formulation. Said PI0924661-4 further describes antimicrobial formulations containing, for instance, 2-methyl-cyclohexylpentanol. However, said document does not mention or suggest the use of said active or formulations thereof as antiperspirant deodorants with dermo-calming action, especially for after-depilation sensitized skin. 
         [0009]    U.S. Pat. No. 8,115,033, published on Feb. 14, 2012, in the name of Symrise Ag relates to the chemical compound 3-(4-hydroxy-3-methoxyphenyl)-1-(4-hydroxyphenyl)-1-propanone, which is different from the chemical compound of the present invention called SymDeo® B125: 2-methyl-5-cyclohexylpentanol. In the same way as the above-cited document, U.S. Pat. No. 8,115,033 does not mention or suggest the use of the active presently described and claimed or its formulations as antiperspirant deodorants with dermo-calming action, or use on after-depilation sensitized skin. In addition, even if this were the case, this is an active ingredient that is not foreseen in the composition of the present invention. 
         [0010]    U.S. Pat. No. 6,172,016, published on Jan. 9, 2001, in the name of Bush Boakes Allen Inc., is directed to the use of pentane derivatives as cosmetic ingredients. The difference with respect to the chemical compounds SymDeo of the present invention lies in the carbon to which the methyl radical is attached, which is the third one in the American patent, namely: 3-methyl-5-cyclohexylpentanol. Again, this is a document that foresees a deodorant composition without the after-depilation calming benefit for sensitized skins. 
         [0011]    Therefore, the need to develop antiperspirant deodorant formulations with dermo-calming action still remains, particularly for sensitized skins, which, in addition to the deodorant and antiperspirant properties, will exhibit emollient sensorial characteristics and a protective film, and provide dermo-calming action on the skin. Such need is fully met with the composition of the present invention. 
       SUMMARY OF THE INVENTION 
       [0012]    The present invention relates to antiperspirant deodorant cosmetic compositions with dermo-calming action, which comprise as active ingredients, 2-methyl-5-cyclohexylpentanol and aluminum hydrochloride, as well as commercially acceptable adjuvants, directed to application in the cosmetic, hygiene and body-care industry. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0013]      FIG. 1  refers to the result of treatment average as a function of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-03) versus control composition on erythema induced by the tape-stripping technique. 
           [0014]      FIG. 2  refers to the result of variation percentage in the average of the test for instrumental evaluation of the effect of the composition of the present invention (called 13-39540-03) versus control composition on erythema induced by the tape stripping technique. 
           [0015]      FIG. 3  refers to the result of the average difference as a function of the time T0 of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-03) versus control composition on erythema induced by the tape-stripping technique. 
           [0016]      FIG. 4  refers to the result of treatment average as a function of the time of the test for instrumental evaluation of the effect of the composition of the present invention (called 13-39540-04) versus control composition on erythema induced by the tape-stripping technique. 
           [0017]      FIG. 5  refers to the result of variation percentage in the average of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-04) versus control composition on erythema induced by the tape-stripping technique. 
           [0018]      FIG. 6  refers to the result of average difference as a function of the time T0 of the test for instrumental evaluation of the effect of the composition of the invention (called 13039540-04) versus control composition on erythema induced by the tape-stripping technique. 
           [0019]      FIG. 7  refers to the result of treatment average as a function of the time of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-01) versus control composition on erythema induced by the tape-stripping technique. 
           [0020]      FIG. 8  refers to the result of variation percentage in the average of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-01) versus control composition on erythema induced by the tape-stripping technique. 
           [0021]      FIG. 9  refers to the result of average difference as a function of the time T0 of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-01) versus control composition on erythema induced by the tape-stripping technique. 
           [0022]      FIG. 10  refers to the result of treatment average as a function of the time of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-02) versus control composition on erythema induced by the tape-stripping technique. 
           [0023]      FIG. 11  refers to the result of variation percentage in the average of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-02) versus control composition on erythema induced by the tape-stripping technique. 
           [0024]      FIG. 12  refers to the result of average difference as a function of the time T0 of the test for instrumental evaluation of the effect of the composition of the invention (called 13-39540-02) versus control composition on erythema induced by the tape-stripping technique. 
           [0025]      FIG. 13  refers to the average value of the erythema (E) for the product and control evaluated as a function of the time referring to the test for evaluation of the reduction of the erythema by using the composition of the invention (called NT1123-12-A). 
           [0026]      FIG. 14  refers to the average value of the reduction the erythema (% RE) for the product and control evaluated as a function of the time referring to the test for evaluation of the reduction of erythema by using the composition of the invention (called NT1123-12-A). 
           [0027]      FIG. 15  refers to the average value of the intensity of the erythema (+a*) for the product and control evaluated referring to the test for evaluation of the reduction of erythema by using the composition of the invention (called NT1123-12-A). 
           [0028]      FIG. 16  refers to percentage of reduction of the intensity of the erythema (% RIE) as a function of the time referring to the test for evaluation of the reduction of erythema by using the composition of the invention (called NT1123-13-A). 
           [0029]      FIG. 17  refers to the result of treatment average as a function of the test for instrumental evaluation of the effect of the composition of the invention (called 12-33171-07) versus control composition on erythema induced by the tape-stripping technique. 
           [0030]      FIG. 18  refers to the result of variation percentage in the average of the test for instrumental evaluation of the effect of the composition of the invention (called 12-33171-7) versus control composition on erythema induced by the tape-stripping technique. 
           [0031]      FIG. 19  refers to the result of average difference as a function of the time T0 of the test for instrumental evaluation of the effect of the composition of the invention (called 12-33171-07) versus control composition on erythema induced by the tape-stripping technique. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0032]    The antiperspirant deodorant cosmetic compositions with dermo-calming action of the present invention comprise 2-methyl-5-cyclohexylpentanol and aluminum hydrochloride and derivatives thereof as active ingredients, as well as cosmetically acceptably adjuvants. 
         [0033]    Said adjuvants suitable for the purposes of the cosmetic compositions of the invention are selected, for example, from the group consisting of demineralized water, oils, emulsifiers, preservatives, sequestrants (chelating agents), fragrance and others cosmetically acceptable components. 
         [0034]    A few examples of inert adjuvants and constituents compatible with the properties of the compositions described herein and that, additionally, may be employed in the present cosmetic composition are given hereinafter—in a non-restrictive, but only demonstrative manner
       Water: water is the base of a number of preferred embodiments of the cosmetic composition of the present invention, acting as a carrier for other components. The compositions of the present invention comprise water, preferably demineralized or distilled at a suitable percentage (q.s.p.) for reaching 100% of the formula, based on the total weight of the present composition. Naturally, one may use other cosmetically acceptable carriers in the present invention;   skin conditioning agent pantenol;   emollients: olus oil, stearylic PPG-15 ether, dicapryl carbonate, silicones, cyclometicone, dimeticonol, cyclopentasyloxane, hydrogenated palm oil;   antioxidant agents: butylated hydroxidetoluene (BHT), butylated hydroxide anisol (BHA), among other;   chelating agents: EDTA, among others;   consistency agents: silica dimethyl sililate, magnesium silicate (talc), ceresin wax, hydroxypropyl starch phosphate; and   emulsifying agents: steareth-2, steareth-21, cetostearyl alcohol, ceteareth-20.       
 
         [0042]    The composition according to the present invention may be present in different cosmetic forms as, for instance, and without any limitation, in the form of roll-on or cream deodorant. 
         [0043]    According to a preferred embodiment of the present invention, the deodorant cosmetic composition of the present invention comprises:
       2-methyl-5-cyclohexylpentanol in an amount ranging from 0.1 to 1% by weight, preferably from 0.3 to 0.5%, more preferably 0.4% as a deodorant active ingredient;   50% solution of aluminum hydrochloride in an amount ranging from 5.0 to 40% by weight, preferably from 10 to 35%, more preferably 30%, as an active ingredient and antiperspirant agent;   Pantenol in an amount ranging from 0.5 to 5% by weight, preferably from 0.8 to 3%, more preferably from 1 to 1.5% as a skin conditioning agent;   BHT in an amount ranging from 0.1 to 0.5% by weight, preferably from 0.04 to 0.3%, more preferably 0.05% as an antioxidant agent;   DMDM hydantoin in an amount ranging from 0.1 to 1% by weight, preferably from 0.3 to 0.8%, more preferably 0.6% as a preservative agent;   EDTA in an amount ranging from 0.05 to 0.5% by weight, preferably from 0.08 to 0.2%, more preferably 0.1% as a chelating agent;   Silica dimethyl silicate, magnesium silicate (talc), ceresin wax, hydroxypropylic starch phosphate in an amount ranging from 0.05 to 6% by weight, preferably from 0.08 to 5%, more preferably from 0.15 to 4%, as a consistency agent;   Olus soil, stearylic PPG-15 ether, hydrogenated palm oil, dicapryl carbonate, cyclomethicone silicones, dimethiconol, cyclopentasiloxane, in an amount ranging from 0.5 to 15% by weight, preferably from 0.8 to 10%, more preferably from 0.1 to 7% as emollients; and   Steareth-2, steareth-21, cetostearyl alcohol, ceteareth-20 in an amount ranging from 0.5 to 15% by weight, preferably from 1.0 to 10%, more preferably from 1.1 to 9.5% as emulsifying agents.       
 
         [0053]    The antiperspirant deodorant cosmetic composition with dermo-calming action of the present invention has a number of advantages and desired characteristics with the ideal and balanced combination between its components, some of which are listed below:
       differentiated antiperspirant protection;   differentiated viscosity;   differentiated hydration;   protective film characteristic;   differentiated softness; and   dermo-calming action, particularly for sensitized skins.       
 
         [0060]    The embodiments of the invention exemplified hereinafter are intended to illustrate, without limiting, the scope of their object. 
       EXAMPLES 
     Example 1 
     The Cosmetic Composition of the Present Invention in Roll-on Form (Called 12-33171-07) 
       [0061]    Table 1 below presents an example of formulation of the cosmetic composition according to the present invention in roll-on form. 
         [0000]    
       
         
               
               
             
               
               
             
           
               
                 TABLE 1 
               
               
                   
               
               
                 Component 
                 Concentration (% by weight) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Demineralized water 
                 56.3 
               
               
                 Aluminum hydrochloride (50% solution) 
                 30.0 
               
               
                 Olus oil 
                 3.8 
               
               
                 Steareth-2 
                 3.0 
               
               
                 Hydroxypropylic starch phosphate 
                 1.5 
               
               
                 Steareth-21 
                 1.1 
               
               
                 Stearylic PPG-15 ether 
                 1.0 
               
               
                 Perfume 
                 1.0 
               
               
                 Pantenol 
                 1.0 
               
               
                 DMDM hydantoin 
                 0.6 
               
               
                 2-methyl-5-cyclohexylpentanol 
                 0.4 
               
               
                 Silica dimethyl silicate 
                 0.15 
               
               
                 Disodium EDTA 
                 0.1 
               
               
                 BHT 
                 0.05 
               
               
                   
               
             
          
         
       
     
       Example 2 
     The Cosmetic Composition of the Present Invention in Roll-on Form (Called 13-39540-01) without Olus Oil 
       [0062]    Table 2 below presents one more example of formulation of the cosmetic composition according to the present invention in roll-on form. 
         [0000]    
       
         
               
               
             
               
               
             
           
               
                 TABLE 2 
               
               
                   
               
               
                 Component 
                 Concentration (wt.-%) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Demineralized water 
                 60.1 
               
               
                 Aluminum hydrochloride (50% solution) 
                 30.0 
               
               
                 Steareth-2 
                 3.0 
               
               
                 Hydroxypropylic starch phosphate 
                 1.5 
               
               
                 Steareth-21 
                 1.1 
               
               
                 Stearylic PPG-15 ether 
                 1.0 
               
               
                 Perfume 
                 1.0 
               
               
                 Pantenol 
                 1.0 
               
               
                 DMDM hidantoin 
                 0.6 
               
               
                 2-methyl-5-cyclohexylpentanol 
                 0.4 
               
               
                 Silica dimethyl silicate 
                 0.15 
               
               
                 Disodium EDTA 
                 0.1 
               
               
                 BHT 
                 0.05 
               
               
                   
               
             
          
         
       
     
       Example 3 
     The Composition of the Present Invention in Roll-On Form (Called 13-39540-02 (with Palm Oil) 
       [0063]    Table 3 below presents one more example of formulation of the cosmetic composition according to the present invention in roll-on form. 
         [0000]    
       
         
               
               
             
               
               
             
           
               
                 TABLE 3 
               
               
                   
               
               
                 Component 
                 Concentration (wt.-%) 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Demineralized water 
                 59.1 
               
               
                 Aluminum hydrochloride (50% solution) 
                 30.0 
               
               
                 Steareth-2 
                 3.0 
               
               
                 Hydroxypropylic starch phosphate 
                 1.5 
               
               
                 Steareth-21 
                 1.1 
               
               
                 Stearylic PPG-15 ether 
                 1.0 
               
               
                 Hydrogenated palm oil 
                 1.0 
               
               
                 Perfume 
                 1.0 
               
               
                 Pantenol 
                 1.0 
               
               
                 DMDM hydantoin 
                 0.6 
               
               
                 2-methyl-5-cyclohexylpentanol 
                 0.4 
               
               
                 Silica dimethyl silicate 
                 0.15 
               
               
                 Disodium EDTA 
                 0.1 
               
               
                 BHT 
                 0.05 
               
               
                   
               
             
          
         
       
     
       Example 4 
     The Cosmetic Composition of the Present Invention in Cream Form (Deo Cream NT1123-12-A) 
       [0064]    Table 4 below presents a formulation of the cosmetic composition according to the present invention in cream form. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                 TABLE 4 
               
               
                   
                   
               
               
                   
                 Component 
                 Concentration (wt.-%) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Demineralized water 
                 41.7 
               
               
                   
                 Aluminum hydrochloride 
                 30.0 
               
               
                   
                 Cetosterayl alcohol 
                 7.5 
               
               
                   
                 Olus oil 
                 3.8 
               
               
                   
                 Ceresin 
                 3.0 
               
               
                   
                 Cyclopentasyloxane 
                 2.5 
               
               
                   
                 Talc 
                 2.0 
               
               
                   
                 Hydroxypropylic starch phosphate 
                 2.0 
               
               
                   
                 Steareth-20 
                 1.75 
               
               
                   
                 Pantenol 
                 1.5 
               
               
                   
                 Perfume 
                 1.1 
               
               
                   
                 Dicapryl carbonate 
                 1.0 
               
               
                   
                 Dimethiconol, cyclopentasiloxane 
                 1.0 
               
               
                   
                 DMDM hydantoin 
                 0.6 
               
               
                   
                 2-methyl-5-cyclohexylpentanol 
                 0.4 
               
               
                   
                 Disodium EDTA 
                 0.1 
               
               
                   
                 BHT 
                 0.05 
               
               
                   
                   
               
             
          
         
       
     
       Example 5 
     The Cosmetic Composition of the Present Invention in Cream Form (Called 13-39540-03) 
       [0065]    Table 5 below presents a formulation of the cosmetic composition according to the present invention in cream form. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                 TABLE 5 
               
               
                   
                   
               
               
                   
                 Component 
                 Concentration (wt.-%) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Demineralized water 
                 45.5 
               
               
                   
                 Aluminum hydrochloride 
                 30.0 
               
               
                   
                 Cetosterayl alcohol 
                 7.5 
               
               
                   
                 Ceresin 
                 3.0 
               
               
                   
                 Cyclopentasiloxane 
                 2.5 
               
               
                   
                 Talc 
                 2.0 
               
               
                   
                 Hydroxypropylic starch phostate 
                 2.0 
               
               
                   
                 Ceteareth-20 
                 1.75 
               
               
                   
                 Pantenol 
                 1.5 
               
               
                   
                 Perfume 
                 1.1 
               
               
                   
                 Dicapryl carbonate 
                 1.0 
               
               
                   
                 Dimethiconol, cyclopeontasiloxane 
                 1.0 
               
               
                   
                 DMDM hydantoin 
                 0.6 
               
               
                   
                 2.-methyl-5-cyclohexylpoentanol 
                 0.4 
               
               
                   
                 Disodium EDTA 
                 0.1 
               
               
                   
                 BHT 
                 0.05 
               
               
                   
                   
               
             
          
         
       
     
       Example 6 
     The Cosmetic Composition of the Present Invention in Cream Form (Called 13-39540-04) 
       [0066]    Table 6 below presents a formulation of the cosmetic composition according to the present invention in cream form. 
         [0000]    
       
         
               
               
               
             
               
               
               
             
           
               
                   
                 TABLE 6 
               
               
                   
                   
               
               
                   
                 Component 
                 Concentration (wt.-%) 
               
               
                   
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 Demineralized water 
                 44.5 
               
               
                   
                 Aluminum hydrochloride 
                 30.0 
               
               
                   
                 Cetostearyl alcohol 
                 7.5 
               
               
                   
                 Cerasin 
                 3.0 
               
               
                   
                 cyclopeontasiloxane 
                 2.5 
               
               
                   
                 Talc 
                 2.0 
               
               
                   
                 Hydroxypropylic starch phosphate 
                 2.0 
               
               
                   
                 Ceteareth-20 
                 1.75 
               
               
                   
                 Pantenol 
                 1.5 
               
               
                   
                 Perfume 
                 1.1 
               
               
                   
                 Hydrogenated palm oil 
                 1.0 
               
               
                   
                 Dicapryl carbonate 
                 1.0 
               
               
                   
                 Dimethiconol, cyclopentasiloxane 
                 1.0 
               
               
                   
                 DMDM hydantoin 
                 0.6 
               
               
                   
                 2-methyl-5-cydohexylpentanol 
                 0.4 
               
               
                   
                 Disodium EDTA 
                 0.1 
               
               
                   
                 BHT 
                 0.05 
               
               
                   
                   
               
             
          
         
       
     
         [0067]    The cosmetic composition of the present invention is prepared in a conventional way, known to those skilled in the art. 
         [0068]    Tests: 
         [0069]    Test 1—Instrumental Evaluation of the Effect of the Composition of the Invention (Called 13-39540-03) on Erythema Caused by the Tape-Stripping Technique. 
       1.1—Objective 
       [0070]    Evaluating the potential of a calming action of a topical product referring to a composition according to the invention through instrumental measurements of colorimetry. 
       1.2 Methodology, Materials and Equipment 
       [0071]    Two symmetrical 10 cm 2  areas having randomized distribution in the front region of the forearms of the patients (a total of 21 participants) were demarcated. One of the areas was used for application of the product and the other was kept as control (untreated area). Colorimetric measurements were made with the equipment Mexameter MX18-Courge+Khazaka prior to tape-stripping removal (Fita Hipoalergênica Transproe MR ) and application of the product (Tb) after 30 tape-stripping removals at each site (T0) and after 30 minutes, 1, 2, 3, 4, 5 and 6 hours from application of the product. 
       1.3—Measurement of Erythema-Mexametry 
       [0072]    The measurements were carried out by using the equipment Mexameter MX 18, Courage+Khazaka electronic GmbH through a measurement probe. The readings were made by applying the probe to the test areas with the pressure permitted by the spring (0.5 N). 
         [0073]    The measurement area was 5 mm in diameter. Three measurements were carried out in each area. The measurement consisted in measuring the light absorbed and reflected at the wavelengths for green and red for hemoglobin and wavelengths for green and near infrared for melanin. 
         [0074]    The operator positioned the probe vertically, forming a 90-degree angle with the skin and cleaned the probe with the aid of a very soft piece of paper prior to the first reading and between the readings of one area an another, even if it were the control area or the initial measurement of each area. 
         [0075]    The reading indicated the degree of erythema of the skin. The scale of the equipment is arbitrary, the reading values indicating greater redness of the skin (erythema). 
       1.4—Steps of Research 
     1.4.1—First Step 
       [0000]    
       
         
           
             The participants remained at rest in an air-conditioned room with temperature of 20±2° C. and relative humidity of 50±5% for at least 30 minutes prior to each reading; 
             The participants were told not to smoke; not to come out of the test room without prior authorization of the expert; not to come into contact with the area being tested at any place; not to contact the area being tested in contact with the clothes between the first air-conditioning and the end of the measurements; not to make abrupt movements with any part of the body; and not to allow the test area to get wet 
             The participants were evaluated by the dermatologist to confirm the research inclusion criteria; 
             Two symmetric 10 cm 2  areas of the region before the forearms having randomized distribution were demarcated. One area was used for application of the product and the other area was kept as negative control (untreated area); and 
             One determined the coloration of the areas through arithmetic mean of three measurements (Tb). 
           
         
       
     
       1.4.2—Second Step 
       [0000]    
       
         
           
             30 tape-stripping removals were carried out in the two demarcated areas. The adhesive tapes (TransporeMR) were replaced at each removal; and 
             One determined the coloration of the demarcated areas through the arithmetic mean of three measurements (T0). 
           
         
       
     
       1.4.3—Third Step 
       [0000]    
       
         
           
             The tested product was applied in a randomized manner, in the amount of 0.02 g in the demarcated region of each participant. The product was spread over the skin with the aid of a latex fingerstall, with light and circular movements until the whole application area was entirely covered and homogeneous. The latex fingerstall was changed in each area; 
             The measurements were carried out in the following times: 
             T30min—thirty minutes after application of the product 
             T1h—one hour after application of the product 
             T2h—two hours after application of the product 
             T3h—three hours after application of the product; 
             T4h—four hours after application of the product; 
             T5h—five hours after application of the product; 
             T6h—six hours after application of the product. 
             The participants were evaluated by the dermatologist at the end of the measurements T6h; and 
             After the medical evaluation the participants were released. 
           
         
       
     
       1.5—Statistical Analysis 
       [0094]    For a statistical analysis of the results, different tests were employed, as follows: 
         [0095]    In order to compare the treatments in each time, one used ANOVA, followed by the DUNNET test and to compare the times with regard to the initial time T0, one used the Student test t. 
         [0096]    As said before, the number of participants of the research was 21 and all of them completed the study in question. 
         [0097]    The trust level considered in the comparative analyses was of 96%. 
       1.6—Results 
     1.6.1—Measurement of Erythema-Mexametry 
       [0098]      
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
             
           
               
                 TABLE 7 
               
             
             
               
                   
               
               
                 Measurements, descriptive statistics and results of the comparison 
               
             
          
           
               
                 Participant of the 
                 13-39540-03 
                 Control 
                 13-39540-03 
                 Control 
               
             
          
           
               
                 research 
                 Tb 
                 T0 
                 Tb 
                 T0 
                 Δ(T0 − Tb) 
                 Δ(T0 − Tb) 
               
               
                   
               
             
          
           
               
                 001 
                 242 
                 352 
                 265 
                 358 
                 110 
                 93 
               
               
                 002 
                 343 
                 493 
                 363 
                 478 
                 150 
                 115 
               
               
                 003 
                 333 
                 454 
                 317 
                 423 
                 121 
                 106 
               
               
                 004 
                 251 
                 385 
                 272 
                 399 
                 134 
                 127 
               
               
                 005 
                 240 
                 480 
                 280 
                 451 
                 240 
                 171 
               
               
                 006 
                 451 
                 551 
                 395 
                 465 
                 100 
                 70 
               
               
                 007 
                 361 
                 479 
                 366 
                 459 
                 118 
                 93 
               
               
                 008 
                 342 
                 450 
                 354 
                 448 
                 108 
                 94 
               
               
                 009 
                 298 
                 456 
                 323 
                 391 
                 158 
                 68 
               
               
                 010 
                 357 
                 452 
                 401 
                 467 
                 95 
                 66 
               
               
                 011 
                 343 
                 430 
                 374 
                 407 
                 87 
                 33 
               
               
                 012 
                 276 
                 299 
                 264 
                 323 
                 23 
                 59 
               
               
                 013 
                 337 
                 432 
                 368 
                 455 
                 95 
                 87 
               
               
                 014 
                 362 
                 452 
                 346 
                 448 
                 90 
                 102 
               
               
                 015 
                 284 
                 377 
                 335 
                 407 
                 93 
                 72 
               
               
                 017 
                 312 
                 477 
                 316 
                 405 
                 165 
                 89 
               
               
                 018 
                 234 
                 412 
                 242 
                 376 
                 178 
                 134 
               
               
                 019 
                 282 
                 357 
                 306 
                 374 
                 75 
                 68 
               
               
                 020 
                 304 
                 458 
                 266 
                 455 
                 154 
                 189 
               
               
                 021 
                 267 
                 360 
                 267 
                 336 
                 93 
                 69 
               
               
                 022 
                 285 
                 365 
                 248 
                 309 
                 80 
                 61 
               
               
                 Average 
                 309.7 
                 427.2 
                 317.5 
                 411.1 
                 117.5 
                 93.6 
               
               
                 Medium 
                 304.0 
                 450.0 
                 317.0 
                 407.0 
                 108.0 
                 89.0 
               
               
                 Minimum 
                 234.0 
                 299.0 
                 242.0 
                 309.0 
                 23.0 
                 33.0 
               
               
                 Maximum 
                 451.0 
                 551.0 
                 401.0 
                 478.0 
                 240.0 
                 189.0 
               
               
                 Standard error 
                 11.5 
                 13.1 
                 11.0 
                 11.0 
                 10.0 
                 8.2 
               
               
                 IC of 95% 
                 [286.6; 
                 [401.0; 
                 [295.6; 
                 [389.1; 
                 [97.5; 
                 [77.2; 
               
               
                   
                 332.8] 
                 453.3] 
                 339.5] 
                 433.2] 
                 137.4] 
                 110.0] 
               
             
          
           
               
                 Δ (%) with respect to T0 
                 37.9 
                 29.5 
               
               
                 % of participants with irritating effect 
                 100.0 
                 100.0 
               
               
                 P-Value 
                 &lt;0.001*** 
                 &lt;0.001*** 
               
               
                   
               
               
                 ***significant at level 0.1%; 
               
               
                 **significant at level 1%; 
               
               
                 *significant at level 5% (Student t test) 
               
             
          
         
       
     
         [0099]    The T0 was higher on average than the Tb for product and control. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 8 
               
               
                   
               
               
                 Measurements and descriptive statistics of the product 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ(T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Participant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 001 
                 352 
                 217 
                 216 
                 270 
                 265 
                 300 
                 292 
                 275 
                 −135 
               
               
                 002 
                 493 
                 308 
                 345 
                 376 
                 409 
                 392 
                 395 
                 402 
                 −185 
               
               
                 003 
                 454 
                 225 
                 266 
                 328 
                 337 
                 368 
                 343 
                 346 
                 −229 
               
               
                 004 
                 385 
                 224 
                 251 
                 225 
                 251 
                 281 
                 254 
                 248 
                 −161 
               
               
                 005 
                 480 
                 326 
                 353 
                 348 
                 361 
                 365 
                 379 
                 378 
                 −154 
               
               
                 006 
                 551 
                 437 
                 451 
                 471 
                 458 
                 495 
                 492 
                 484 
                 −114 
               
               
                 007 
                 479 
                 370 
                 358 
                 353 
                 369 
                 379 
                 389 
                 381 
                 −109 
               
               
                 008 
                 450 
                 313 
                 288 
                 301 
                 322 
                 347 
                 340 
                 351 
                 −137 
               
               
                 009 
                 456 
                 332 
                 350 
                 339 
                 389 
                 387 
                 384 
                 380 
                 −124 
               
               
                 010 
                 452 
                 359 
                 332 
                 358 
                 338 
                 358 
                 340 
                 361 
                 −93 
               
               
                 011 
                 430 
                 320 
                 311 
                 328 
                 309 
                 308 
                 339 
                 351 
                 −110 
               
               
                 012 
                 299 
                 263 
                 275 
                 235 
                 280 
                 263 
                 289 
                 276 
                 −36 
               
               
                 013 
                 432 
                 373 
                 358 
                 353 
                 380 
                 382 
                 376 
                 360 
                 −59 
               
               
                 014 
                 452 
                 344 
                 352 
                 368 
                 358 
                 356 
                 361 
                 364 
                 −108 
               
               
                 015 
                 377 
                 278 
                 273 
                 279 
                 300 
                 309 
                 311 
                 323 
                 −99 
               
               
                 017 
                 477 
                 320 
                 347 
                 372 
                 377 
                 400 
                 394 
                 376 
                 −157 
               
               
                 018 
                 412 
                 240 
                 240 
                 266 
                 257 
                 265 
                 278 
                 264 
                 −172 
               
               
                 019 
                 357 
                 244 
                 248 
                 270 
                 270 
                 264 
                 283 
                 290 
                 −113 
               
               
                 020 
                 458 
                 393 
                 366 
                 401 
                 398 
                 407 
                 442 
                 401 
                 −65 
               
               
                 021 
                 360 
                 254 
                 293 
                 282 
                 305 
                 326 
                 307 
                 337 
                 −106 
               
               
                 022 
                 365 
                 305 
                 277 
                 287 
                 292 
                 252 
                 274 
                 280 
                 −60 
               
               
                 Average 
                 427.2 
                 306.9 
                 311.9 
                 324.3 
                 334.5 
                 343.0 
                 345.8 
                 344.2 
                 −120.3 
               
               
                 Medium 
                 450.0 
                 313.0 
                 311.0 
                 328.0 
                 337.0 
                 356.0 
                 340.0 
                 351.0 
                 −113.0 
               
               
                 Minimum 
                 299.0 
                 217.0 
                 216.0 
                 225.0 
                 251.0 
                 252.0 
                 254.0 
                 248.0 
                 −229.0 
               
               
                 Maximum 
                 551.0 
                 437.0 
                 451.0 
                 471.0 
                 458.0 
                 495.0 
                 492.0 
                 484.0 
                 −36.0 
               
               
                 Standard 
                 13.1 
                 13.3 
                 12.3 
                 13.0 
                 12.3 
                 13.3 
                 13.1 
                 12.4 
                 10.1 
               
               
                 error 
               
               
                 IC de 
                 [401.0; 
                 [280.4; 
                 [287.4; 
                 [298.3; 
                 [309.9; 
                 [316.4; 
                 [319.6; 
                 [319.4; 
                 [−140.5; 
               
               
                 95% 
                 453.3] 
                 333.4] 
                 336.5] 
                 350.2] 
                 359.2] 
                 369.7] 
                 372.0] 
                 369.0] 
                 −100.1] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 −28.2 
               
               
                   
               
             
          
           
               
                   
                   
                 Δ(T1 h − 
                 Δ(T2 h − 
                 Δ(T3 h − 
                 Δ(T4 h − 
                 Δ(T5 h − 
                 Δ(T6 h − 
               
               
                   
                 Participant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
                   
               
               
                   
                 001 
                 −136 
                 −82 
                 −87 
                 −52 
                 −60 
                 −77 
               
               
                   
                 002 
                 −148 
                 −117 
                 −84 
                 −101 
                 −98 
                 −91 
               
               
                   
                 003 
                 −188 
                 −126 
                 −117 
                 −86 
                 −111 
                 −108 
               
               
                   
                 004 
                 −134 
                 −160 
                 −134 
                 −104 
                 −131 
                 −137 
               
               
                   
                 005 
                 −127 
                 −132 
                 −119 
                 −115 
                 −101 
                 −102 
               
               
                   
                 006 
                 −100 
                 −80 
                 −93 
                 −56 
                 −59 
                 −67 
               
               
                   
                 007 
                 −121 
                 −126 
                 −110 
                 −100 
                 −90 
                 −98 
               
               
                   
                 008 
                 −162 
                 −149 
                 −128 
                 −103 
                 −110 
                 −99 
               
               
                   
                 009 
                 −106 
                 −117 
                 −67 
                 −69 
                 −72 
                 −76 
               
               
                   
                 010 
                 −120 
                 −94 
                 −114 
                 −94 
                 −112 
                 −91 
               
               
                   
                 011 
                 −119 
                 −102 
                 −121 
                 −122 
                 −91 
                 −79 
               
               
                   
                 012 
                 −24 
                 −64 
                 −19 
                 −36 
                 −10 
                 −23 
               
               
                   
                 013 
                 −74 
                 −79 
                 −52 
                 −50 
                 −56 
                 −72 
               
               
                   
                 014 
                 −100 
                 −84 
                 −94 
                 −96 
                 −91 
                 −88 
               
               
                   
                 015 
                 −104 
                 −98 
                 −77 
                 −68 
                 −66 
                 −54 
               
               
                   
                 017 
                 −130 
                 −105 
                 −100 
                 −77 
                 −83 
                 −101 
               
               
                   
                 018 
                 −172 
                 −146 
                 −155 
                 −147 
                 −134 
                 −148 
               
               
                   
                 019 
                 −109 
                 −87 
                 −87 
                 −93 
                 −74 
                 −67 
               
               
                   
                 020 
                 −92 
                 −57 
                 −60 
                 −51 
                 −16 
                 −57 
               
               
                   
                 021 
                 −67 
                 −78 
                 −55 
                 −34 
                 −53 
                 −23 
               
               
                   
                 022 
                 −88 
                 −78 
                 −73 
                 −113 
                 −91 
                 −85 
               
               
                   
                 Average 
                 −115.3 
                 −102.9 
                 −92.7 
                 −84.1 
                 −81.4 
                 −83.0 
               
               
                   
                 Medium 
                 −119.0 
                 −98.0 
                 −93.0 
                 −93.0 
                 −90.0 
                 −85.0 
               
               
                   
                 Minimum 
                 −188.0 
                 −160.0 
                 −155.0 
                 −147.0 
                 −134.0 
                 −148.0 
               
               
                   
                 Maximum 
                 −24.0 
                 −57.0 
                 −19.0 
                 −34.0 
                 −10.0 
                 −23.0 
               
               
                   
                 Standard 
                 8.1 
                 6.3 
                 7.0 
                 6.6 
                 7.1 
                 6.6 
               
               
                   
                 error 
               
               
                   
                 IC de 
                 [−131.4; 
                 [−115.5; 
                 [−106.7; 
                 [−97.3; 
                 [−95.5; 
                 [−96.3; 
               
               
                   
                 95% 
                 −99.2] 
                 −90.3] 
                 −78.6] 
                 −71.0] 
                 −67.2] 
                 −69.7] 
               
             
          
           
               
                   
                 Δ (%) with 
                 −27.0 
                 −24.1 
                 −21.7 
                 −19.7 
                 −19.1 
                 −19.4 
               
               
                   
                 respect to 
               
               
                   
                 the T0 
               
               
                   
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 9 
               
               
                   
               
               
                 Descriptive measurements and statistics of the control 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ(T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Participant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 001 
                 358 
                 261 
                 281 
                 290 
                 320 
                 332 
                 335 
                 346 
                 −97 
               
               
                 002 
                 478 
                 397 
                 429 
                 399 
                 421 
                 413 
                 422 
                 433 
                 −81 
               
               
                 003 
                 423 
                 289 
                 328 
                 319 
                 321 
                 346 
                 331 
                 332 
                 −134 
               
               
                 004 
                 399 
                 231 
                 266 
                 261 
                 268 
                 293 
                 277 
                 286 
                 −168 
               
               
                 005 
                 451 
                 349 
                 344 
                 349 
                 392 
                 346 
                 366 
                 361 
                 −102 
               
               
                 006 
                 465 
                 416 
                 411 
                 391 
                 402 
                 406 
                 399 
                 389 
                 −49 
               
               
                 007 
                 459 
                 387 
                 372 
                 351 
                 356 
                 375 
                 384 
                 367 
                 −72 
               
               
                 008 
                 448 
                 356 
                 334 
                 344 
                 346 
                 377 
                 359 
                 367 
                 −92 
               
               
                 009 
                 391 
                 356 
                 361 
                 343 
                 354 
                 365 
                 361 
                 364 
                 −35 
               
               
                 010 
                 467 
                 393 
                 382 
                 385 
                 375 
                 428 
                 394 
                 379 
                 −74 
               
               
                 011 
                 407 
                 347 
                 334 
                 331 
                 352 
                 353 
                 364 
                 360 
                 −60 
               
               
                 012 
                 323 
                 270 
                 275 
                 235 
                 259 
                 250 
                 260 
                 270 
                 −53 
               
               
                 013 
                 455 
                 437 
                 425 
                 405 
                 429 
                 422 
                 403 
                 416 
                 −18 
               
               
                 014 
                 448 
                 363 
                 354 
                 380 
                 386 
                 389 
                 375 
                 371 
                 −85 
               
               
                 015 
                 407 
                 328 
                 336 
                 323 
                 324 
                 344 
                 331 
                 349 
                 −79 
               
               
                 017 
                 405 
                 293 
                 316 
                 332 
                 340 
                 352 
                 338 
                 353 
                 −112 
               
               
                 018 
                 376 
                 217 
                 219 
                 240 
                 269 
                 277 
                 282 
                 257 
                 −159 
               
               
                 019 
                 374 
                 272 
                 291 
                 276 
                 289 
                 284 
                 304 
                 295 
                 −102 
               
               
                 020 
                 455 
                 365 
                 346 
                 326 
                 324 
                 349 
                 347 
                 350 
                 −90 
               
               
                 021 
                 336 
                 267 
                 258 
                 275 
                 297 
                 302 
                 302 
                 328 
                 −69 
               
               
                 022 
                 309 
                 278 
                 260 
                 247 
                 240 
                 226 
                 203 
                 223 
                 −31 
               
               
                 Average 
                 411.1 
                 327.2 
                 329.6 
                 323.9 
                 336.4 
                 344.2 
                 339.9 
                 342.7 
                 −83.9 
               
               
                 Medium 
                 407.0 
                 347.0 
                 334.0 
                 331.0 
                 340.0 
                 349.0 
                 347.0 
                 353.0 
                 −81.0 
               
               
                 Minimum 
                 309.0 
                 217.0 
                 219.0 
                 235.0 
                 240.0 
                 226.0 
                 203.0 
                 223.0 
                 −168.0 
               
               
                 Maximum 
                 478.0 
                 437.0 
                 429.0 
                 405.0 
                 429.0 
                 428.0 
                 422.0 
                 433.0 
                 −18.0 
               
               
                 Standard 
                 11.0 
                 13.7 
                 12.5 
                 11.6 
                 11.7 
                 12.1 
                 11.7 
                 11.2 
                 8.4 
               
               
                 error 
               
               
                 IC of 
                 [389.1; 
                 [299.9; 
                 [304.6; 
                 [300.7; 
                 [313.0; 
                 [320; 
                 [316.4; 
                 [320.2; 
                 [−100.7; 
               
               
                 95% 
                 433.2] 
                 354.6] 
                 354.6] 
                 347.1] 
                 359.7] 
                 368.5] 
                 363.3] 
                 365.1] 
                 −67.1] 
               
             
          
           
               
                 Δ (%) em relação ao T0 
                 −20.4 
               
               
                   
               
             
          
           
               
                   
                   
                 Δ(T1 h − 
                 Δ(T2 h − 
                 Δ(T3 h − 
                 Δ(T4 h − 
                 Δ(T5 h − 
                 Δ(T6 h − 
               
               
                   
                 Participant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
                   
               
               
                   
                 001 
                 −77 
                 −68 
                 −38 
                 −26 
                 −23 
                 −12 
               
               
                   
                 002 
                 −49 
                 −79 
                 −57 
                 −65 
                 −56 
                 −45 
               
               
                   
                 003 
                 −95 
                 −104 
                 −102 
                 −77 
                 −92 
                 −91 
               
               
                   
                 004 
                 −133 
                 −138 
                 −131 
                 −106 
                 −122 
                 −113 
               
               
                   
                 005 
                 −107 
                 −102 
                 −59 
                 −105 
                 −85 
                 −90 
               
               
                   
                 006 
                 −54 
                 −74 
                 −63 
                 −59 
                 −66 
                 −76 
               
               
                   
                 007 
                 −87 
                 −108 
                 −103 
                 −84 
                 −75 
                 −92 
               
               
                   
                 008 
                 −114 
                 −104 
                 −102 
                 −71 
                 −89 
                 −81 
               
               
                   
                 009 
                 −30 
                 −48 
                 −37 
                 −26 
                 −30 
                 −27 
               
               
                   
                 010 
                 −85 
                 −82 
                 −92 
                 −39 
                 −73 
                 −88 
               
               
                   
                 011 
                 −73 
                 −76 
                 −55 
                 −54 
                 −43 
                 −47 
               
               
                   
                 012 
                 −48 
                 −88 
                 −64 
                 −73 
                 −63 
                 −53 
               
               
                   
                 013 
                 −30 
                 −50 
                 −26 
                 −33 
                 −52 
                 −39 
               
               
                   
                 014 
                 −94 
                 −68 
                 −62 
                 −59 
                 −73 
                 −77 
               
               
                   
                 015 
                 −71 
                 −84 
                 −83 
                 −63 
                 −76 
                 −58 
               
               
                   
                 017 
                 −89 
                 −73 
                 −65 
                 −53 
                 −67 
                 −52 
               
               
                   
                 018 
                 −157 
                 −136 
                 −107 
                 −99 
                 −94 
                 −119 
               
               
                   
                 019 
                 −83 
                 −98 
                 −85 
                 −90 
                 −70 
                 −79 
               
               
                   
                 020 
                 −109 
                 −129 
                 −131 
                 −106 
                 −108 
                 −105 
               
               
                   
                 021 
                 −78 
                 −61 
                 −39 
                 −34 
                 −34 
                 −8 
               
               
                   
                 022 
                 −49 
                 −62 
                 −69 
                 −83 
                 −106 
                 −86 
               
               
                   
                 Average 
                 −81.5 
                 −87.2 
                 −74.8 
                 −66.9 
                 −71.3 
                 −68.5 
               
               
                   
                 Medium 
                 −83.0 
                 −82.0 
                 −65.0 
                 −65.0 
                 −73.0 
                 −77.0 
               
               
                   
                 Minimum 
                 −157.0 
                 −138.0 
                 −131.0 
                 −106.0 
                 −122.0 
                 −119.0 
               
               
                   
                 Maximum 
                 −30.0 
                 −48.0 
                 −26.0 
                 −26.0 
                 −23.0 
                 −8.0 
               
               
                   
                 Standard 
                 7.0 
                 5.7 
                 6.6 
                 5.7 
                 5.7 
                 6.8 
               
               
                   
                 error 
               
               
                   
                 IC of 
                 [−95.6; 
                 [−98.6; 
                 [−87.9; 
                 [−78.3; 
                 [−82.7; 
                 [−82.1; 
               
               
                   
                 95% 
                 −67.5] 
                 −75.8] 
                 −61.7] 
                 −55.5] 
                 −59.9] 
                 −54.8] 
               
             
          
           
               
                   
                 Δ (%) em 
                 −19.8 
                 −21.2 
                 −18.2 
                 −16.3 
                 −17.3 
                 −16.7 
               
               
                   
                 relação 
               
               
                   
                 ao T0 
               
               
                   
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 10 
               
             
             
               
                   
               
               
                 Average and standard error of each treatment per time, and the difference 
               
               
                 between the treatments 
               
             
          
           
               
                   
                 Product 
                 Control 
                 Product − Control 
               
             
          
           
               
                 Time 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
               
               
                   
               
             
          
           
               
                 T0 
                   
                 427.19 
                 13.08 
                 411.14 
                 11.02 
                 16.05 
                 7.26 
               
               
                 T30 
                 min 
                 306.90 
                 13.26 
                 327.24 
                 13.69 
                 −20.33 
                 7.17 
               
               
                 T1 
                 h 
                 311.90 
                 12.28 
                 329.62 
                 12.49 
                 −17.71 
                 8.39 
               
               
                 T2 
                 h 
                 324.29 
                 12.98 
                 323.90 
                 11.60 
                 0.38 
                 7.82 
               
               
                 T3 
                 h 
                 334.52 
                 12.32 
                 336.38 
                 11.67 
                 −1.86 
                 8.05 
               
               
                 T4 
                 h 
                 343.05 
                 13.32 
                 344.24 
                 12.13 
                 −1.19 
                 8.48 
               
               
                 T5 
                 h 
                 345.81 
                 13.10 
                 339.86 
                 11.73 
                 5.95 
                 9.21 
               
               
                 T6 
                 h 
                 344.19 
                 12.40 
                 342.67 
                 11.24 
                 1.52 
                 8.23 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
             
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 11 
               
             
             
               
                   
               
               
                 Porcentage of variation on the average with respect to the time T0, 
               
               
                 and percentage of participants with positive and negative effect 
               
             
          
           
               
                   
                 Product - Control 
               
             
          
           
               
                   
                 % of variation 
                 % of participants 
                 % of participants 
               
               
                   
                 with respect 
                 with positive 
                 with negative 
               
             
          
           
               
                 Time 
                 to the T0 
                 effect 
                 effect 
               
               
                   
               
             
          
           
               
                 T30 
                 min 
                 −7.7 
                 85.7 
                 14.3 
               
               
                 T1 
                 h 
                 −7.2 
                 85.7 
                 14.3 
               
               
                 T2 
                 h 
                 −2.9 
                 85.7 
                 14.3 
               
               
                 T3 
                 h 
                 −3.5 
                 85.7 
                 14.3 
               
               
                 T4 
                 h 
                 −3.4 
                 76.2 
                 19.0 
               
               
                 T5 
                 h 
                 −1.7 
                 76.2 
                 23.8 
               
               
                 T6 
                 h 
                 −2.8 
                 71.4 
                 28.6 
               
               
                   
               
             
          
         
       
     
         [0100]    The product exhibited greater reduction with respect to the T0 in the average values of erythema compared with the control in the times T30min (p-value &lt;0.0001), T1h (p-value=0.0001), T2h (p-value=0.0155), T3h (p-value=0.0253) and T4h (p-value=0.0163). No significant differences were found between the product and the control in the times T5h (p-value=0.2834) and T6h (p-value=0.0528). 
         [0101]    The times T30min, T1h, T2h, T3h, T4h, T5h and T6h were lower than the time T0 for the product (p-values &lt;0.001). 
       Wherein: 
       [0102]    cm 2 : square centimeters;
 
g: grams;
 
h: hours;
 
no.: number;
 
° C.: degrees Centigrade;
 
Tx: time after x hours of application of the product.
 
       1.7—Conclusion 
       [0103]    After the statistical analysis of the results, one can conclude that the composition of the invention promoted reduction of the erythema caused by the tape-stripping technique until the time of 4 hours. 
         [0104]    Test 2—Instrumental Evaluation of the Effect of the Composition of the Invention (Called 13-29540-04) on the Erythema Caused by the Tape-Stripping Technique 
       2.1—Objective 
       [0105]    Evaluating the potential of calming action of a topical product referring to a composition according to the invention through instrumental colorimetric measurement. 
       2.2—Methodology, Materials and Equipment 
       [0106]    Two symmetric 10 cm 2  areas of randomized distribution in the region before the forearms of the participants (a total of 21 participants) were demarcated. One of the areas was used for application of the product and the other was kept as control (untreated area). Colorimetric measurements were made with the equipment Mexameter MX18-Courage+Khazaka before tape-stripping removal (Fita Hipoalergên Transpore MR ) and application of the product (Tb), after the 30 tape-stripping removals at each site (T0) and after 30 minutes, 1, 2, 3, 4, 5 and 6 hours of application of the product. 
       2.3—Measurement of Erythema-Mexametry 
       [0107]    The measurements were carried out by using the equipment Mexameter MX 18, Courage+Khazaka electronic GmbH through a measurement probe. The readings were made by applying the probe to the test areas with the pressure permitted by the spring (0.5 N). 
         [0108]    The measurement area was 5 mm in diameter. Three measurements were carried out in each area. The measurement consisted in measuring the light absorbed and reflected at the wavelengths for green and red for hemoglobin and wavelengths for green and near infrared for melanin. 
         [0109]    The operator positioned the probe vertically, forming a 90-degree angle with the skin and cleaned the probe with the aid of a very soft piece of paper prior to the first reading and between the readings of one area an another, even if it were the control area or the initial measurement of each area. 
         [0110]    The reading indicated the degree of erythema of the skin. The scale of the equipment is arbitrary, the reading values indicating greater redness of the skin (erythema). 
       2.4—Steps of Research 
     2.4.1—First Step 
       [0000]    
       
         
           
             The participants remained at rest in an air-conditioned room with temperature of 20±2° C. and relative humidity of 50±5% for at least 30 minutes prior to each reading; 
             The participants were told not to smoke; not to come out of the test room without prior authorization of the expert; not to come into contact with the area being tested at any place; not to contact the area being tested in contact with the clothes between the first air-conditioning and the end of the measurements; not to make abrupt movements with any part of the body; and not to allow the test area to get wet 
             The participants were evaluated by the dermatologist to confirm the research inclusion criteria; 
             Two symmetric 10 cm 2  areas of the region before the forearms having randomized distribution were demarcated. One area was used for application of the product and the other area was kept as negative control (untreated area); and 
             One determined the coloration of the areas through arithmetic mean of three measurements (Tb). 
           
         
       
     
       2.4.2—Second Step 
       [0000]    
       
         
           
             30 tape-stripping removals were carried out in the two demarcated areas. The adhesive tapes (TransporeMR) were replaced at each removal; and 
             One determined the coloration of the demarcated areas through the arithmetic mean of three measurements (T0). 
           
         
       
     
       2.4.3—Third Step 
       [0000]    
       
         
           
             The tested product was applied in a randomized manner, in the amount of 0.02 g in the demarcated region of each participant. The product was spread over the skin with the aid of a latex fingerstall, with light and circular movements until the whole application area was entirely covered and homogeneous. The latex fingerstall was changed in each area; 
             The measurements were carried out in the following times: 
             T30min—thirty minutes after application of the product 
             T1h—one hour after application of the product 
             T2h—two hours after application of the product 
             T3h—three hours after application of the product; 
             T4h—four hours after application of the product; 
             T5h—five hours after application of the product; 
             T6h—six hours after application of the product. 
             The participants were evaluated by the dermatologist at the end of the measurements T6h; and 
             After the medical evaluation the participants were released. 
           
         
       
     
       2.5—Statistical Analysis 
       [0129]    For a statistical analysis of the results, different tests were employed, as follows: 
         [0130]    In order to compare the treatments in each time, one used ANOVA, followed by the DUNNET test and to compare the times with regard to the initial time T0, one used the Student test t. 
         [0131]    As said before, the number of participants of the research was 21 and all of them completed the study in question. 
         [0132]    The trust level considered in the comparative analyses was of 96%. 
       2.6—Results 
     2.6.1—Measurement of Erythema-Mexametry 
       [0133]      
         [0000]                                                                                                                          TABLE 12                   Measurements, descriptive statistics and results of the comparison            Participant            of the   13-39540-04   Control   13-39540-04   Control            research   Tb   T0   Tb   T0   Δ(T0 − Tb)   Δ(T0 − Tb)                    001   279   374   265   358   95   93       002   300   426   363   478   126   115       003   303   428   317   423   125   106       004   264   395   272   399   131   127       005   236   412   280   451   176   171       006   403   505   395   465   102   70       007   403   484   366   459   81   93       008   358   442   354   448   84   94       009   309   428   323   391   119   68       010   383   459   401   467   76   66       011   350   417   374   407   67   33       012   313   389   264   323   76   59       013   360   407   368   455   47   87       014   326   388   346   448   62   102       015   302   398   335   407   96   72       017   304   344   316   405   40   89       018   244   423   242   376   179   134       019   279   383   306   374   104   68       020   306   410   266   455   104   189       021   220   371   267   336   151   69       022   270   301   248   309   31   61       Average   310.1   408.8   317.5   411.1   98.7   93.6       Medium   304.0   410.0   317.0   407.0   96.0   89.0       Minimum   220.0   301.0   242.0   309.0   31.0   33.0       Maximum   403.0   505.0   401.0   478.0   179.0   189.0       Standard   11.2   9.8   11.0   11.0   8.8   8.2       error       IC of 95%   [287.6; 332.6]   [389.2; 428.3]   [295.6; 339.5]   [389.1; 433.2]   [81.0; 116.3]   [77.2; 110.0]            Δ(%) with respect to the T0   31.8   29.5       % of participants with irritating effect   100.0   100.0       P-Value   &lt;0.001***   &lt;0.001***               ***significant at level 0.1%;       **significant at level 1%;       *significant at level 5% (t-Student test).            
The T0 was hither on the average than the Tb for product and control
 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
             
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 13 
               
               
                   
               
               
                 Measurements and descriptive statistics of the product 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Partici- 
                   
                 T30- 
                   
                   
                   
                   
                   
                   
               
               
                 pant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
               
               
                   
               
               
                 001 
                 374 
                 235 
                 257 
                 280 
                 295 
                 334 
                 331 
                 346 
               
               
                 002 
                 426 
                 284 
                 263 
                 323 
                 341 
                 328 
                 347 
                 331 
               
               
                 003 
                 428 
                 234 
                 266 
                 276 
                 314 
                 340 
                 328 
                 317 
               
               
                 004 
                 395 
                 246 
                 276 
                 267 
                 270 
                 295 
                 293 
                 290 
               
               
                 005 
                 412 
                 263 
                 273 
                 307 
                 298 
                 304 
                 285 
                 289 
               
               
                 006 
                 505 
                 380 
                 390 
                 408 
                 423 
                 441 
                 424 
                 428 
               
               
                 007 
                 484 
                 391 
                 388 
                 380 
                 385 
                 389 
                 398 
                 394 
               
               
                 008 
                 442 
                 312 
                 304 
                 275 
                 313 
                 319 
                 321 
                 332 
               
               
                 009 
                 428 
                 321 
                 336 
                 331 
                 353 
                 401 
                 344 
                 371 
               
               
                 010 
                 459 
                 369 
                 375 
                 388 
                 392 
                 416 
                 417 
                 386 
               
               
                 011 
                 417 
                 355 
                 323 
                 335 
                 350 
                 350 
                 386 
                 353 
               
               
                 012 
                 389 
                 324 
                 305 
                 295 
                 294 
                 311 
                 290 
                 306 
               
               
                 013 
                 407 
                 362 
                 373 
                 342 
                 390 
                 371 
                 354 
                 378 
               
               
                 014 
                 388 
                 292 
                 315 
                 330 
                 319 
                 317 
                 297 
                 306 
               
               
                 015 
                 398 
                 300 
                 311 
                 309 
                 314 
                 332 
                 311 
                 313 
               
               
                 017 
                 344 
                 257 
                 282 
                 280 
                 307 
                 321 
                 303 
                 311 
               
               
                 018 
                 423 
                 260 
                 264 
                 283 
                 284 
                 300 
                 290 
                 290 
               
               
                 019 
                 383 
                 254 
                 259 
                 258 
                 275 
                 280 
                 294 
                 275 
               
               
                 020 
                 410 
                 345 
                 317 
                 312 
                 359 
                 348 
                 335 
                 349 
               
               
                 021 
                 371 
                 226 
                 244 
                 264 
                 270 
                 260 
                 271 
                 284 
               
               
                 022 
                 301 
                 251 
                 244 
                 245 
                 251 
                 222 
                 213 
                 227 
               
               
                 Average 
                 408.8 
                 298.1 
                 303.1 
                 309.0 
                 323.7 
                 332.3 
                 325.3 
                 327.4 
               
               
                 Medium 
                 410.0 
                 292.0 
                 304.0 
                 307.0 
                 314.0 
                 328.0 
                 321.0 
                 317.0 
               
               
                 Minimum 
                 301.0 
                 226.0 
                 244.0 
                 245.0 
                 251.0 
                 222.0 
                 213.0 
                 227.0 
               
               
                 Maximum 
                 505.0 
                 391.0 
                 390.0 
                 408.0 
                 423.0 
                 441.0 
                 424.0 
                 428.0 
               
               
                 Standard 
                 9.8 
                 11.6 
                 10.3 
                 9.7 
                 10.2 
                 11.3 
                 11.1 
                 10.3 
               
               
                 error 
               
               
                 IC of 95% 
                 [389.2; 428.3] 
                 [275.0; 321.2] 
                 [282.5; 323.6] 
                 [289.6; 328.3] 
                 [303.3; 344.1] 
                 [309.8; 354.9] 
                 [303.1; 347.6] 
                 [306.9; 348.0] 
               
             
          
           
               
                 Δ(%) em relação ao T0 
               
               
                   
               
             
          
           
               
                   
                   
                 Δ(T30- 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 Partici- 
                 min − 
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                   
                 pant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
                   
               
               
                   
                 001 
                 −139 
                 −117 
                 −94 
                 −79 
                 −40 
                 −43 
                 −28 
               
               
                   
                 002 
                 −142 
                 −163 
                 −103 
                 −85 
                 −98 
                 −79 
                 −95 
               
               
                   
                 003 
                 −194 
                 −162 
                 −152 
                 −114 
                 −88 
                 −100 
                 −111 
               
               
                   
                 004 
                 −149 
                 −119 
                 −128 
                 −125 
                 −100 
                 −102 
                 −105 
               
               
                   
                 005 
                 −149 
                 −139 
                 −105 
                 −114 
                 −108 
                 −127 
                 −123 
               
               
                   
                 006 
                 −125 
                 −115 
                 −97 
                 −82 
                 −64 
                 −81 
                 −77 
               
               
                   
                 007 
                 −93 
                 −96 
                 −104 
                 −99 
                 −95 
                 −86 
                 −90 
               
               
                   
                 008 
                 −130 
                 −138 
                 −167 
                 −129 
                 −123 
                 −121 
                 −110 
               
               
                   
                 009 
                 −107 
                 −92 
                 −97 
                 −75 
                 −27 
                 −84 
                 −57 
               
               
                   
                 010 
                 −90 
                 −84 
                 −71 
                 −67 
                 −43 
                 −42 
                 −73 
               
               
                   
                 011 
                 −62 
                 −94 
                 −82 
                 −67 
                 −67 
                 −31 
                 −64 
               
               
                   
                 012 
                 −65 
                 −84 
                 −94 
                 −95 
                 −78 
                 −99 
                 −83 
               
               
                   
                 013 
                 −45 
                 −34 
                 −65 
                 −17 
                 −36 
                 −53 
                 −29 
               
               
                   
                 014 
                 −96 
                 −73 
                 −58 
                 −69 
                 −71 
                 −91 
                 −82 
               
               
                   
                 015 
                 −98 
                 −87 
                 −89 
                 −84 
                 −66 
                 −87 
                 −85 
               
               
                   
                 017 
                 −87 
                 −62 
                 −64 
                 −37 
                 −23 
                 −41 
                 −33 
               
               
                   
                 018 
                 −163 
                 −159 
                 −140 
                 −139 
                 −123 
                 −133 
                 −133 
               
               
                   
                 019 
                 −129 
                 −124 
                 −125 
                 −108 
                 −103 
                 −89 
                 −108 
               
               
                   
                 020 
                 −65 
                 −93 
                 −98 
                 −51 
                 −62 
                 −75 
                 −61 
               
               
                   
                 021 
                 −145 
                 −127 
                 −107 
                 −101 
                 −111 
                 −100 
                 −87 
               
               
                   
                 022 
                 −50 
                 −57 
                 −56 
                 −50 
                 −79 
                 −88 
                 −74 
               
               
                   
                 Average 
                 −110.6 
                 −105.7 
                 −99.8 
                 −85.1 
                 −76.4 
                 −83.4 
                 −81.3 
               
               
                   
                 Medium 
                 −107.0 
                 −96.0 
                 −97.0 
                 −84.0 
                 −78.0 
                 −87.0 
                 −83.0 
               
               
                   
                 Minimum 
                 −194.0 
                 −163.0 
                 −167.0 
                 −139.0 
                 −123.0 
                 −133.0 
                 −133.0 
               
               
                   
                 Maximum 
                 −45.0 
                 −34.0 
                 −56.0 
                 −17.0 
                 −23.0 
                 −31.0 
                 −28.0 
               
               
                   
                 Standard 
                 8.8 
                 7.7 
                 6.5 
                 6.8 
                 6.7 
                 6.2 
                 6.4 
               
               
                   
                 error 
               
               
                   
                 IC of 95% 
                 [−128.3; −93.0] 
                 [−121.1; −90.2] 
                 [−112.9; −86.8] 
                 [−98.7; −71.4] 
                 [−89.8; −63.1] 
                 [−95.8; −71.1] 
                 [−94.1; −68.6] 
               
               
                   
                 Δ(%) em 
                 −27.1 
                 −25.9 
                 −24.4 
                 −20.8 
                 −18.7 
                 −20.4 
                 −19.9 
               
               
                   
                 relação 
               
               
                   
                 ao T0 
               
               
                   
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
             
               
             
               
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 14 
               
               
                   
               
               
                 Measurements and descriptive statistics of the control 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                 Partici- 
                   
                 T30- 
                   
                   
                   
                   
                   
                   
               
               
                 pant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
               
               
                   
               
               
                 001 
                 358 
                 261 
                 281 
                 290 
                 320 
                 332 
                 335 
                 346 
               
               
                 002 
                 478 
                 397 
                 429 
                 399 
                 421 
                 413 
                 422 
                 433 
               
               
                 003 
                 423 
                 289 
                 328 
                 319 
                 321 
                 346 
                 331 
                 332 
               
               
                 004 
                 399 
                 231 
                 266 
                 261 
                 268 
                 293 
                 277 
                 286 
               
               
                 005 
                 451 
                 349 
                 344 
                 349 
                 392 
                 346 
                 366 
                 361 
               
               
                 006 
                 465 
                 416 
                 411 
                 391 
                 402 
                 406 
                 399 
                 389 
               
               
                 007 
                 459 
                 387 
                 372 
                 351 
                 356 
                 375 
                 384 
                 367 
               
               
                 008 
                 448 
                 356 
                 334 
                 344 
                 346 
                 377 
                 359 
                 367 
               
               
                 009 
                 391 
                 356 
                 361 
                 343 
                 354 
                 365 
                 361 
                 364 
               
               
                 010 
                 467 
                 393 
                 382 
                 385 
                 375 
                 428 
                 394 
                 379 
               
               
                 011 
                 407 
                 347 
                 334 
                 331 
                 352 
                 353 
                 364 
                 360 
               
               
                 012 
                 323 
                 270 
                 275 
                 235 
                 259 
                 250 
                 260 
                 270 
               
               
                 013 
                 455 
                 437 
                 425 
                 405 
                 429 
                 422 
                 403 
                 416 
               
               
                 014 
                 448 
                 363 
                 354 
                 380 
                 386 
                 389 
                 375 
                 371 
               
               
                 015 
                 407 
                 328 
                 336 
                 323 
                 324 
                 344 
                 331 
                 349 
               
               
                 017 
                 405 
                 293 
                 316 
                 332 
                 340 
                 352 
                 338 
                 353 
               
               
                 018 
                 376 
                 217 
                 219 
                 240 
                 269 
                 277 
                 282 
                 257 
               
               
                 019 
                 374 
                 272 
                 291 
                 276 
                 289 
                 284 
                 304 
                 295 
               
               
                 020 
                 455 
                 365 
                 346 
                 326 
                 324 
                 349 
                 347 
                 350 
               
               
                 021 
                 336 
                 267 
                 258 
                 275 
                 297 
                 302 
                 302 
                 328 
               
               
                 022 
                 309 
                 278 
                 260 
                 247 
                 240 
                 226 
                 203 
                 223 
               
               
                 Average 
                 411.1 
                 327.2 
                 329.6 
                 323.9 
                 336.4 
                 344.2 
                 339.9 
                 342.7 
               
               
                 Medium 
                 407.0 
                 347.0 
                 334.0 
                 331.0 
                 340.0 
                 349.0 
                 347.0 
                 353.0 
               
               
                 Minimum 
                 309.0 
                 217.0 
                 219.0 
                 235.0 
                 240.0 
                 226.0 
                 203.0 
                 223.0 
               
               
                 Maximum 
                 478.0 
                 437.0 
                 429.0 
                 405.0 
                 429.0 
                 428.0 
                 422.0 
                 433.0 
               
               
                 Standard 
                 11.0 
                 13.7 
                 12.5 
                 11.6 
                 11.7 
                 12.1 
                 11.7 
                 11.2 
               
               
                 error 
               
               
                 IC of 95% 
                 [389.1; 433.2] 
                 [299.9; 354.6] 
                 [304.6; 354.6] 
                 [300.7; 347.1] 
                 [313.0; 359.7] 
                 [320; 368.5] 
                 [316.4; 363.3] 
                 [320.2; 365.1] 
               
             
          
           
               
                 Δ(%) wtih respect to the T0 
               
               
                   
               
             
          
           
               
                   
                   
                 Δ(T30- 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 Partici- 
                 min − 
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                   
                 pant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
                   
               
               
                   
                 001 
                 −97 
                 −77 
                 −68 
                 −38 
                 −26 
                 −23 
                 −12 
               
               
                   
                 002 
                 −81 
                 −49 
                 −79 
                 −57 
                 −65 
                 −56 
                 −45 
               
               
                   
                 003 
                 −134 
                 −95 
                 −104 
                 −102 
                 −77 
                 −92 
                 −91 
               
               
                   
                 004 
                 −168 
                 −133 
                 −138 
                 −131 
                 −106 
                 −122 
                 −113 
               
               
                   
                 005 
                 −102 
                 −107 
                 −102 
                 −59 
                 −105 
                 −85 
                 −90 
               
               
                   
                 006 
                 −49 
                 −54 
                 −74 
                 −63 
                 −59 
                 −66 
                 −76 
               
               
                   
                 007 
                 −72 
                 −87 
                 −108 
                 −103 
                 −84 
                 −75 
                 −92 
               
               
                   
                 008 
                 −92 
                 −114 
                 −104 
                 −102 
                 −71 
                 −89 
                 −81 
               
               
                   
                 009 
                 −35 
                 −30 
                 −48 
                 −37 
                 −26 
                 −30 
                 −27 
               
               
                   
                 010 
                 −74 
                 −85 
                 −82 
                 −92 
                 −39 
                 −73 
                 −88 
               
               
                   
                 011 
                 −60 
                 −73 
                 −76 
                 −55 
                 −54 
                 −43 
                 −47 
               
               
                   
                 012 
                 −53 
                 −48 
                 −88 
                 −64 
                 −73 
                 −63 
                 −53 
               
               
                   
                 013 
                 −18 
                 −30 
                 −50 
                 −26 
                 −33 
                 −52 
                 −39 
               
               
                   
                 014 
                 −85 
                 −94 
                 −68 
                 −62 
                 −59 
                 −73 
                 −77 
               
               
                   
                 015 
                 −79 
                 −71 
                 −84 
                 −83 
                 −63 
                 −76 
                 −58 
               
               
                   
                 017 
                 −112 
                 −89 
                 −73 
                 −65 
                 −53 
                 −67 
                 −52 
               
               
                   
                 018 
                 −159 
                 −157 
                 −136 
                 −107 
                 −99 
                 −94 
                 −119 
               
               
                   
                 019 
                 −102 
                 −83 
                 −98 
                 −85 
                 −90 
                 −70 
                 −79 
               
               
                   
                 020 
                 −90 
                 −109 
                 −129 
                 −131 
                 −106 
                 −108 
                 −105 
               
               
                   
                 021 
                 −69 
                 −78 
                 −61 
                 −39 
                 −34 
                 −34 
                 −8 
               
               
                   
                 022 
                 −31 
                 −49 
                 −62 
                 −69 
                 −83 
                 −106 
                 −86 
               
               
                   
                 Average 
                 −83.9 
                 −81.5 
                 −87.2 
                 −74.8 
                 −66.9 
                 −71.3 
                 −68.5 
               
               
                   
                 Medium 
                 −81.0 
                 −83.0 
                 −82.0 
                 −65.0 
                 −65.0 
                 −73.0 
                 −77.0 
               
               
                   
                 Minimum 
                 −168.0 
                 −157.0 
                 −138.0 
                 −131.0 
                 −106.0 
                 −122.0 
                 −119.0 
               
               
                   
                 Maximum 
                 −18.0 
                 −30.0 
                 −48.0 
                 −26.0 
                 −26.0 
                 −23.0 
                 −8.0 
               
               
                   
                 Standard 
                 8.4 
                 7.0 
                 5.7 
                 6.6 
                 5.7 
                 5.7 
                 6.8 
               
               
                   
                 error 
               
               
                   
                 IC of 95% 
                 [−100.7; −67.1] 
                 [−95.6; −67.5] 
                 [−98.6; −75.8] 
                 [−87.9; −61.7] 
                 [−78.3; −55.5] 
                 [−82.7; −59.9] 
                 [−82.1; −54.8] 
               
               
                   
                 Δ(%) wtih 
                 −20.4 
                 −19.8 
                 −21.2 
                 −18.2 
                 −16.3 
                 −17.3 
                 −16.7 
               
               
                   
                 respect 
               
               
                   
                 to the T0 
               
               
                   
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 15 
               
             
             
               
                   
               
               
                 Average and standard error of each treatment per time and the difference 
               
               
                 between the treatments 
               
             
          
           
               
                   
                 Product 
                 Control 
                 Product − Cotrol 
               
             
          
           
               
                 Time 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
               
               
                   
               
             
          
           
               
                 T0 
                   
                 408.76 
                 9.77 
                 411.14 
                 11.02 
                 −2.38 
                 8.14 
               
               
                 T30 
                 min 
                 298.14 
                 11.55 
                 327.24 
                 13.69 
                 −29.10 
                 8.74 
               
               
                 T1 
                 h 
                 303.10 
                 10.28 
                 329.62 
                 12.49 
                 −26.52 
                 9.26 
               
               
                 T2 
                 h 
                 308.95 
                 9.67 
                 323.90 
                 11.60 
                 −14.95 
                 7.92 
               
               
                 T3 
                 h 
                 323.67 
                 10.21 
                 336.38 
                 11.67 
                 −12.71 
                 7.88 
               
               
                 T4 
                 h 
                 332.33 
                 11.26 
                 344.24 
                 12.13 
                 −11.90 
                 8.05 
               
               
                 T5 
                 h 
                 325.33 
                 11.14 
                 339.86 
                 11.73 
                 −14.52 
                 7.56 
               
               
                 T6 
                 h 
                 327.43 
                 10.29 
                 342.67 
                 11.24 
                 −15.24 
                 8.17 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
             
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 16 
               
             
             
               
                   
               
               
                 Porcentage of variation on the average with respect to the time T0, 
               
               
                 and percentage of participants with positive and negative effect 
               
             
          
           
               
                   
                 Product - Control 
               
             
          
           
               
                   
                 % of variation 
                 % of subjects 
                 % of subjects 
               
               
                   
                 with respect 
                 with positive 
                 with negative 
               
             
          
           
               
                 Time 
                 to the T0 
                 effect 
                 effect 
               
               
                   
               
             
          
           
               
                 T30 
                 min 
                 −6.7 
                 85.7 
                 14.3 
               
               
                 T1 
                 h 
                 −6.0 
                 76.2 
                 23.8 
               
               
                 T2 
                 h 
                 −3.2 
                 66.7 
                 33.3 
               
               
                 T3 
                 h 
                 −2.6 
                 66.7 
                 33.3 
               
               
                 T4 
                 h 
                 −2.4 
                 81.0 
                 19.0 
               
               
                 T5 
                 h 
                 −3.1 
                 71.4 
                 28.6 
               
               
                 T6 
                 h 
                 −3.2 
                 66.7 
                 33.3 
               
               
                   
               
             
          
         
       
     
         [0134]    The product exhibited greater reduction with respect to the T0 in the average values of erythema compared with the control in the times T30min (p-value=0.0004) and T1h (p-value=0.0031). No significant differences were found between product and control in the times T2h (p-value=0.0571), T3h (p-value=o.0571), T3h (p-value=0.2448), T4h (p-value=0.2311), T5h (p-value=0.1731) and T6h (p-value=0.0925). 
         [0135]    The times T30min, T1h, T2h, T3h, T4h, T5h and T6h were lower that the T0 for the product (p-values &lt;0.001); 
         [0000]    wherein:
 
cm2: square centimeters;
 
g: grams;
 
h: hours;
 
no.: number;
 
° C.: degrees Centigrade;
 
Tx: Time after x hours of application of the product.
 
       2.7—Conclusion 
       [0136]    After a statistic analysis of the results, one can conclude that the composition of the invention promoted reduction of the erythema caused by the tape-stripping technique until the time of 1 hour. 
         [0137]    Test 3—Instrumental Evaluation of the Effect of the Composition of the Invention (Called 13-39540-01) on the Erythema Caused by the Tape-Stripping Technique 
       3.1—Objective 
       [0138]    Evaluating the potential of a calming action of a topical product referring to a composition according to the invention through instrumental measurements of colorimetry. 
         [0000]    3.2—Methodology. Materials and Equipment 
         [0139]    Two symmetrical 10 cm 2  areas having randomized distribution in the front region of the forearms of the patients (a total of 21 participants) were demarcated. One of the areas was used for application of the product and the other was kept as control (untreated area). Colorimetric measurements were made with the equipment Mexameter MX18-Couage+Khazaka prior to tape-stripping removal (Fita Hipoalergênica Transproe MR ) and application of the product (Tb) after 30 tape-stripping removals at each site (T0) and after 30 minutes, 1, 2, 3, 4, 5 and 6 hours from application of the product. 
       3.3—Measurement of Erythema-Mexametry 
       [0140]    The measurements were carried out by using the equipment Mexameter MX 18, Courage+Khazaka electronic GmbH through a measurement probe. The readings were made by applying the probe to the test areas with the pressure permitted by the spring (0.5 N). 
         [0141]    The measurement area was 5 mm in diameter. Three measurements were carried out in each area. The measurement consisted in measuring the light absorbed and reflected at the wavelengths for green and red for hemoglobin and wavelengths for green and near infrared for melanin. 
         [0142]    The operator positioned the probe vertically, forming a 90-degree angle with the skin and cleaned the probe with the aid of a very soft piece of paper prior to the first reading and between the readings of one area an another, even if it were the control area or the initial measurement of each area. 
         [0143]    The reading indicated the degree of erythema of the skin. The scale of the equipment is arbitrary, the reading values indicating greater redness of the skin (erythema). 
       3.4—Steps of Research 
     3.4.1—First Step 
       [0000]    
       
         
           
             The participants remained at rest in an air-conditioned room with temperature of 20±2° C. and relative humidity of 50±5% for at least 30 minutes prior to each reading; 
             The participants were told not to smoke; not to come out of the test room without prior authorization of the expert; not to come into contact with the area being tested at any place; not to contact the area being tested in contact with the clothes between the first air-conditioning and the end of the measurements; not to make abrupt movements with any part of the body; and not to allow the test area to get wet 
             The participants were evaluated by the dermatologist to confirm the research inclusion criteria; 
             Two symmetric 10 cm 2  areas of the region before the forearms having randomized distribution were demarcated. One area was used for application of the product and the other area was kept as negative control (untreated area); and 
             One determined the coloration of the areas through arithmetic mean of three measurements (Tb). 
           
         
       
     
       3.4.2—Second Step 
       [0000]    
       
         
           
             30 tape-stripping removals were carried out in the two demarcated areas. The adhesive tapes (TransporeMR) were replaced at each removal; and 
             One determined the coloration of the demarcated areas through the arithmetic mean of three measurements (T0). 
           
         
       
     
       3.4.3—Third Step 
       [0000]    
       
         
           
             The tested product was applied in a randomized manner, in the amount of 0.02 g in the demarcated region of each participant. The product was spread over the skin with the aid of a latex fingerstall, with light and circular movements until the whole application area was entirely covered and homogeneous. The latex fingerstall was changed in each area; 
             The measurements were carried out in the following times: 
             T30min—thirty minutes after application of the product 
             T1h—one hour after application of the product 
             T2h—two hours after application of the product 
             T3h—three hours after application of the product; 
             T4h—four hours after application of the product; 
             T5h—five hours after application of the product; 
             T6h—six hours after application of the product. 
             The participants were evaluated by the dermatologist at the end of the measurements T6h; and 
             After the medical evaluation the participants were released. 
           
         
       
     
       3.5—Statistical Analysis 
       [0162]    For a statistical analysis of the results, different tests were employed, as follows: 
         [0163]    In order to compare the treatments in each time, one used ANOVA, followed by the DUNNET test and to compare the times with regard to the initial time T0, one used the Student test t. 
         [0164]    As said before, the number of participants of the research was 21 and all of them completed the study in question. 
         [0165]    The trust level considered in the comparative analyses was of 96%. 
       3.6—Results 
     3.6.1—Measurement of Erythema-Mexametry 
       [0166]      
         [0000]                                                                                                                    TABLE 17                   Measurements, descriptive statistics and results of the comparison            Participant da   13-39540-01   Control   13-39540-01   Control            pesquisa   Tb   T0   Tb   T0   Δ (T0 − Tb)   Δ (T0 − Tb)                    001   338   428   334   428   90   94       002   252   400   278   401   148   123       003   221   354   207   291   133   84       004   292   391   269   396   99   127       005   326   433   334   389   107   55       006   176   323   178   334   147   156       007   365   479   342   451   114   109       008   303   397   268   393   94   125       009   311   421   339   420   110   81       010   245   398   248   391   153   143       011   209   356   238   350   147   112       012   230   363   247   361   133   114       013   278   383   304   486   105   182       014   340   415   347   436   75   89       015   237   318   225   322   81   97       016   228   352   258   368   124   110       017   270   381   234   339   111   105       018   284   411   311   406   127   95       019   226   318   231   318   92   87       020   288   425   263   372   137   109       021   300   362   292   365   62   73       Average   272.3   386.1   273.7   381.8   113.8   108.1       Medium   278.0   391.0   268.0   389.0   111.0   109.0       Minimum   176.0   318.0   178.0   291.0   62.0   55.0       Maximum   365.0   479.0   347.0   486.0   153.0   182.0       Standard error   10.8   9.1   10.5   10.4   5.7   6.3       IC of 95%   [250.8; 293.8]   [367.9; 404.3]   [252.6; 294.8]   [360.9; 402.6]   [102.4; 125.1]   [95.5; 120.7]            Δ (%) with respect to the T0   41.8   39.5       % of participants with irritating effect   100.0   100.0       P-Value   &lt;0.001***   &lt;0.001***               ***significant at level 0.1%;       **significant at level 1%;       *significant at level 5% (t-Student test).            
The T0 was higher on the average than the Tb for product and control
 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 18 
               
               
                   
               
               
                 Measurements and descriptive statistics of the product 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ (T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Participant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 001 
                 428 
                 331 
                 345 
                 371 
                 371 
                 366 
                 376 
                 364 
                 −97 
               
               
                 002 
                 400 
                 270 
                 300 
                 320 
                 320 
                 308 
                 304 
                 317 
                 −130 
               
               
                 003 
                 354 
                 247 
                 260 
                 232 
                 261 
                 209 
                 219 
                 234 
                 −107 
               
               
                 004 
                 391 
                 273 
                 288 
                 313 
                 328 
                 312 
                 321 
                 322 
                 −118 
               
               
                 005 
                 433 
                 298 
                 305 
                 303 
                 302 
                 314 
                 336 
                 346 
                 −135 
               
               
                 006 
                 323 
                 154 
                 159 
                 167 
                 164 
                 168 
                 172 
                 210 
                 −169 
               
               
                 007 
                 479 
                 328 
                 325 
                 300 
                 360 
                 386 
                 376 
                 389 
                 −151 
               
               
                 008 
                 397 
                 263 
                 279 
                 292 
                 277 
                 297 
                 309 
                 291 
                 −134 
               
               
                 009 
                 421 
                 302 
                 312 
                 326 
                 336 
                 332 
                 351 
                 339 
                 −119 
               
               
                 010 
                 398 
                 282 
                 283 
                 304 
                 305 
                 302 
                 298 
                 303 
                 −116 
               
               
                 011 
                 356 
                 232 
                 234 
                 241 
                 245 
                 252 
                 276 
                 257 
                 −124 
               
               
                 012 
                 363 
                 244 
                 234 
                 227 
                 254 
                 268 
                 242 
                 255 
                 −119 
               
               
                 013 
                 383 
                 288 
                 283 
                 303 
                 306 
                 325 
                 319 
                 335 
                 −95 
               
               
                 014 
                 415 
                 353 
                 337 
                 363 
                 379 
                 360 
                 384 
                 392 
                 −62 
               
               
                 015 
                 318 
                 287 
                 277 
                 291 
                 291 
                 300 
                 307 
                 319 
                 −31 
               
               
                 016 
                 352 
                 213 
                 202 
                 217 
                 224 
                 254 
                 244 
                 293 
                 −139 
               
               
                 017 
                 381 
                 280 
                 318 
                 317 
                 315 
                 319 
                 321 
                 326 
                 −101 
               
               
                 018 
                 411 
                 284 
                 270 
                 280 
                 287 
                 324 
                 328 
                 356 
                 −127 
               
               
                 019 
                 318 
                 230 
                 226 
                 239 
                 272 
                 255 
                 264 
                 260 
                 −88 
               
               
                 020 
                 425 
                 310 
                 300 
                 302 
                 297 
                 291 
                 345 
                 345 
                 −115 
               
               
                 021 
                 362 
                 328 
                 317 
                 320 
                 356 
                 353 
                 333 
                 352 
                 −34 
               
               
                 Average 
                 386.1 
                 276.0 
                 278.8 
                 287.0 
                 297.6 
                 299.8 
                 306.0 
                 314.5 
                 −110.0 
               
               
                 Medium 
                 391.0 
                 282.0 
                 283.0 
                 302.0 
                 302.0 
                 308.0 
                 319.0 
                 322.0 
                 −118.0 
               
               
                 Minimum 
                 318.0 
                 154.0 
                 159.0 
                 167.0 
                 164.0 
                 168.0 
                 172.0 
                 210.0 
                 −169.0 
               
               
                 Maximum 
                 479.0 
                 353.0 
                 345.0 
                 371.0 
                 379.0 
                 386.0 
                 384.0 
                 392.0 
                 −31.0 
               
               
                 Standard 
                 9.1 
                 10.0 
                 10.1 
                 10.9 
                 11.3 
                 11.4 
                 11.8 
                 10.8 
                 7.5 
               
               
                 error 
               
               
                 IC of 
                 [367.9; 
                 [256; 
                 [258.5; 
                 [265.3; 
                 [275.1; 
                 [277; 
                 [282.4; 
                 [293; 
                 [−125.1; 
               
               
                 95% 
                 404.3] 
                 296.1] 
                 299] 
                 308.8] 
                 320.1] 
                 322.5] 
                 329.5] 
                 336.1] 
                 −95] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 −28.5 
               
               
                   
               
             
          
           
               
                   
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                 Participant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
               
               
                 001 
                 −83 
                 −57 
                 −57 
                 −62 
                 −52 
                 −64 
               
               
                 002 
                 −100 
                 −80 
                 −80 
                 −92 
                 −96 
                 −83 
               
               
                 003 
                 −94 
                 −122 
                 −93 
                 −145 
                 −135 
                 −120 
               
               
                 004 
                 −103 
                 −78 
                 −63 
                 −79 
                 −70 
                 −69 
               
               
                 005 
                 −128 
                 −130 
                 −131 
                 −119 
                 −97 
                 −87 
               
               
                 006 
                 −164 
                 −156 
                 −159 
                 −155 
                 −151 
                 −113 
               
               
                 007 
                 −154 
                 −179 
                 −119 
                 −93 
                 −103 
                 −90 
               
               
                 008 
                 −118 
                 −105 
                 −120 
                 −100 
                 −88 
                 −106 
               
               
                 009 
                 −109 
                 −95 
                 −85 
                 −89 
                 −70 
                 −82 
               
               
                 010 
                 −115 
                 −94 
                 −93 
                 −96 
                 −100 
                 −95 
               
               
                 011 
                 −122 
                 −115 
                 −111 
                 −104 
                 −80 
                 −99 
               
               
                 012 
                 −129 
                 −136 
                 −109 
                 −95 
                 −121 
                 −108 
               
               
                 013 
                 −100 
                 −80 
                 −77 
                 −58 
                 −64 
                 −48 
               
               
                 014 
                 −78 
                 −52 
                 −36 
                 −55 
                 −31 
                 −23 
               
               
                 015 
                 −41 
                 −27 
                 −27 
                 −18 
                 −11 
                 1 
               
               
                 016 
                 −150 
                 −135 
                 −128 
                 −98 
                 −108 
                 −59 
               
               
                 017 
                 −63 
                 −64 
                 −66 
                 −62 
                 −60 
                 −55 
               
               
                 018 
                 −141 
                 −131 
                 −124 
                 −87 
                 −83 
                 −55 
               
               
                 019 
                 −92 
                 −79 
                 −46 
                 −63 
                 −54 
                 −58 
               
               
                 020 
                 −125 
                 −123 
                 −128 
                 −134 
                 −80 
                 −80 
               
               
                 021 
                 −45 
                 −42 
                 −6 
                 −9 
                 −29 
                 −10 
               
               
                 Average 
                 −107.3 
                 −99.0 
                 −88.5 
                 −86.3 
                 −80.1 
                 −71.6 
               
               
                 Medium 
                 −109.0 
                 −95.0 
                 −93.0 
                 −92.0 
                 −80.0 
                 −80.0 
               
               
                 Minimum 
                 −164.0 
                 −179.0 
                 −159.0 
                 −155.0 
                 −151.0 
                 −120.0 
               
               
                 Maximum 
                 −41.0 
                 −27.0 
                 −6.0 
                 −9.0 
                 −11.0 
                 1.0 
               
               
                 Standard 
                 7.3 
                 8.6 
                 8.7 
                 8.0 
                 7.6 
                 7.2 
               
               
                 error 
               
               
                 IC of 
                 [−122; 
                 [−116.2; 
                 [−105.8; 
                 [−102.2; 
                 [−95.3; 
                 [−85.9; −57.2] 
               
               
                 95% 
                 −92.8] 
                 −81.9] 
                 −71.1] 
                 −70.4] 
                 −65] 
               
               
                 Δ (%) with respect to the 
                 −27.8 
                 −25.7 
                 −22.9 
                 −22.4 
                 −20.8 
                 −18.5 
               
               
                 T0 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 19 
               
               
                   
               
               
                 Measurements and descriptive statistics of the control 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ (T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Participant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 001 
                 428 
                 340 
                 351 
                 382 
                 381 
                 384 
                 357 
                 379 
                 −88 
               
               
                 002 
                 401 
                 326 
                 329 
                 337 
                 338 
                 323 
                 333 
                 331 
                 −75 
               
               
                 003 
                 291 
                 245 
                 243 
                 250 
                 249 
                 246 
                 241 
                 234 
                 −46 
               
               
                 004 
                 396 
                 283 
                 315 
                 339 
                 360 
                 352 
                 343 
                 369 
                 −113 
               
               
                 005 
                 389 
                 325 
                 324 
                 331 
                 319 
                 333 
                 349 
                 344 
                 −64 
               
               
                 006 
                 334 
                 180 
                 229 
                 203 
                 214 
                 248 
                 251 
                 260 
                 −154 
               
               
                 007 
                 451 
                 323 
                 360 
                 337 
                 349 
                 382 
                 307 
                 348 
                 −128 
               
               
                 008 
                 393 
                 288 
                 296 
                 308 
                 292 
                 294 
                 287 
                 321 
                 −105 
               
               
                 009 
                 420 
                 361 
                 343 
                 348 
                 368 
                 365 
                 398 
                 383 
                 −59 
               
               
                 010 
                 391 
                 281 
                 306 
                 325 
                 326 
                 325 
                 323 
                 343 
                 −110 
               
               
                 011 
                 350 
                 268 
                 267 
                 262 
                 285 
                 293 
                 306 
                 310 
                 −82 
               
               
                 012 
                 361 
                 270 
                 292 
                 261 
                 312 
                 282 
                 287 
                 301 
                 −91 
               
               
                 013 
                 486 
                 366 
                 377 
                 388 
                 385 
                 399 
                 392 
                 408 
                 −120 
               
               
                 014 
                 436 
                 396 
                 397 
                 412 
                 421 
                 416 
                 432 
                 419 
                 −40 
               
               
                 015 
                 322 
                 270 
                 277 
                 262 
                 267 
                 275 
                 296 
                 294 
                 −52 
               
               
                 016 
                 368 
                 244 
                 222 
                 241 
                 248 
                 264 
                 262 
                 301 
                 −124 
               
               
                 017 
                 339 
                 288 
                 293 
                 310 
                 303 
                 301 
                 305 
                 296 
                 −51 
               
               
                 018 
                 406 
                 319 
                 313 
                 318 
                 312 
                 344 
                 316 
                 338 
                 −87 
               
               
                 019 
                 318 
                 245 
                 225 
                 256 
                 260 
                 260 
                 270 
                 276 
                 −73 
               
               
                 020 
                 372 
                 293 
                 290 
                 279 
                 331 
                 316 
                 348 
                 357 
                 −79 
               
               
                 021 
                 365 
                 305 
                 296 
                 278 
                 308 
                 313 
                 329 
                 316 
                 −60 
               
               
                 Average 
                 381.8 
                 296.0 
                 302.1 
                 306.0 
                 315.6 
                 319.8 
                 320.6 
                 329.9 
                 −85.8 
               
               
                 Medium 
                 389.0 
                 288.0 
                 296.0 
                 310.0 
                 312.0 
                 316.0 
                 316.0 
                 331.0 
                 −82.0 
               
               
                 Minimum 
                 291.0 
                 180.0 
                 222.0 
                 203.0 
                 214.0 
                 246.0 
                 241.0 
                 234.0 
                 −154.0 
               
               
                 Maximum 
                 486.0 
                 396.0 
                 397.0 
                 412.0 
                 421.0 
                 416.0 
                 432.0 
                 419.0 
                 −40.0 
               
               
                 Standard 
                 10.4 
                 10.7 
                 10.6 
                 11.7 
                 11.3 
                 10.9 
                 10.7 
                 10.2 
                 6.7 
               
               
                 error 
               
               
                 IC of 
                 [360.9; 
                 [274.6; 
                 [281; 
                 [282.6; 
                 [293.1; 
                 [298; 
                 [299.2; 
                 [309.4; 
                 [−99.2; 
               
               
                 95% 
                 402.6] 
                 317.4] 
                 323.3] 
                 329.5] 
                 338.2] 
                 341.6] 
                 341.9] 
                 350.4] 
                 −72.3] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 −22.5 
               
               
                   
               
             
          
           
               
                   
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                 Participant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
               
               
                 001 
                 −77 
                 −46 
                 −47 
                 −44 
                 −71 
                 −49 
               
               
                 002 
                 −72 
                 −64 
                 −63 
                 −78 
                 −68 
                 −70 
               
               
                 003 
                 −48 
                 −41 
                 −42 
                 −45 
                 −50 
                 −57 
               
               
                 004 
                 −81 
                 −57 
                 −36 
                 −44 
                 −53 
                 −27 
               
               
                 005 
                 −65 
                 −58 
                 −70 
                 −56 
                 −40 
                 −45 
               
               
                 006 
                 −105 
                 −131 
                 −120 
                 −86 
                 −83 
                 −74 
               
               
                 007 
                 −91 
                 −114 
                 −102 
                 −69 
                 −144 
                 −103 
               
               
                 008 
                 −97 
                 −85 
                 −101 
                 −99 
                 −106 
                 −72 
               
               
                 009 
                 −77 
                 −72 
                 −52 
                 −55 
                 −22 
                 −37 
               
               
                 010 
                 −85 
                 −66 
                 −65 
                 −66 
                 −68 
                 −48 
               
               
                 011 
                 −83 
                 −88 
                 −65 
                 −57 
                 −44 
                 −40 
               
               
                 012 
                 −69 
                 −100 
                 −49 
                 −79 
                 −74 
                 −60 
               
               
                 013 
                 −109 
                 −98 
                 −101 
                 −87 
                 −94 
                 −78 
               
               
                 014 
                 −39 
                 −24 
                 −15 
                 −20 
                 −4 
                 −17 
               
               
                 015 
                 −45 
                 −60 
                 −55 
                 −47 
                 −26 
                 −28 
               
               
                 016 
                 −146 
                 −127 
                 −120 
                 −104 
                 −106 
                 −67 
               
               
                 017 
                 −46 
                 −29 
                 −36 
                 −38 
                 −34 
                 −43 
               
               
                 018 
                 −93 
                 −88 
                 −94 
                 −62 
                 −90 
                 −68 
               
               
                 019 
                 −93 
                 −62 
                 −58 
                 −58 
                 −48 
                 −42 
               
               
                 020 
                 −82 
                 −93 
                 −41 
                 −56 
                 −24 
                 −15 
               
               
                 021 
                 −69 
                 −87 
                 −57 
                 −52 
                 −36 
                 −49 
               
               
                 Average 
                 −79.6 
                 −75.7 
                 −66.1 
                 −62.0 
                 −61.2 
                 −51.9 
               
               
                 Medium 
                 −81.0 
                 −72.0 
                 −58.0 
                 −57.0 
                 −53.0 
                 −49.0 
               
               
                 Minimum 
                 −146.0 
                 −131.0 
                 −120.0 
                 −104.0 
                 −144.0 
                 −103.0 
               
               
                 Maximum 
                 −39.0 
                 −24.0 
                 −15.0 
                 −20.0 
                 −4.0 
                 −15.0 
               
               
                 Standard 
                 5.4 
                 6.4 
                 6.4 
                 4.6 
                 7.5 
                 4.8 
               
               
                 error 
               
               
                 IC of 
                 [−90.4; 
                 [−88.6; 
                 [−78.9; −53.4] 
                 [−71.1; −52.9] 
                 [−76.2; 
                 [−61.4; −42.4] 
               
               
                 95% 
                 −68.8] 
                 −62.9] 
                   
                   
                 −46.2] 
               
               
                 Δ (%) with 
                 −20.9 
                 −19.8 
                 −17.3 
                 −16.2 
                 −16.0 
                 −13.6 
               
               
                 respect to the T0 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 20 
               
             
             
               
                   
               
               
                 Average and standard error of each treatment per time, 
               
               
                 and of the difference between the treatments 
               
             
          
           
               
                   
                 Product 
                 Control 
                 Product − Control 
               
             
          
           
               
                 Time 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
               
               
                   
               
             
          
           
               
                 T0 
                 386.10 
                 9.10 
                 381.76 
                 10.42 
                 4.33 
                 7.32 
               
               
                 T30 min 
                 276.05 
                 10.01 
                 296.00 
                 10.71 
                 −19.95 
                 5.77 
               
               
                 T1 h 
                 278.76 
                 10.14 
                 302.14 
                 10.58 
                 −23.38 
                 6.72 
               
               
                 T2 h 
                 287.05 
                 10.88 
                 306.05 
                 11.70 
                 −19.00 
                 6.01 
               
               
                 T3 h 
                 297.62 
                 11.25 
                 315.62 
                 11.28 
                 −18.00 
                 6.53 
               
               
                 T4 h 
                 299.76 
                 11.38 
                 319.76 
                 10.90 
                 −20.00 
                 6.49 
               
               
                 T5 h 
                 305.95 
                 11.79 
                 320.57 
                 10.67 
                 −14.62 
                 7.50 
               
               
                 T6 h 
                 314.52 
                 10.76 
                 329.90 
                 10.24 
                 −15.38 
                 7.05 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 21 
               
             
             
               
                   
               
               
                 Porcentage of variation in the average with respect to the time 
               
               
                 T0, and percentage of participants with positive and negative effect 
               
             
          
           
               
                   
                 Produto-Controle 
               
             
          
           
               
                   
                 % of 
                 % of  
                 % of  
               
               
                   
                 variation with 
                 participants with 
                 participants with 
               
               
                 Time 
                 respect to the T0 
                 positive effect 
                 negative effect 
               
               
                   
               
             
          
           
               
                 T30  
                 min 
                 −6.0 
                 85.7 
                 14.3 
               
               
                 T1  
                 h 
                 −6.9 
                 81.0 
                 19.0 
               
               
                 T2 
                 h 
                 −5.8 
                 85.7 
                 14.3 
               
               
                 T3 
                 h 
                 −5.6 
                 81.0 
                 19.0 
               
               
                 T4 
                 h 
                 −6.1 
                 81.0 
                 19.0 
               
               
                 T5 
                 h 
                 −4.7 
                 66.7 
                 33.3 
               
               
                 T6 
                 h 
                 −5.0 
                 71.4 
                 28.6 
               
               
                   
               
             
          
         
       
     
         [0167]    The product exhibited greater reduction with respect to the T0 in the average values of erythema compared with the control in the times T30min (p-value=0.0010). T1h (p-value=0.0001), T2h (p-value=0.0008), T3h (p-value=0.0050), T4h (p-value=0.0020), T5h (p-value=0.0136) and T6h (p-value=0.0031). 
         [0168]    The times T30min, T1h, T3h, T4h, T5h and T6h were lower than the time T0 for the product (p-values &lt;0.001). 
       Wherein: 
       [0169]    Cm 2 : square centimeters;
 
G: grams;
 
H: hours;
 
No.: number;
 
       ° C.: Degrees Celsius; 
       [0170]    Tx: Time after x hours of application of the product. 
       6.4—Conclusion 
       [0171]    After a statistic analysis of the results, one can conclude that the composition of the invention promoted reduction of the erythema caused by the tape-stripping technique until the time of 6 hours. 
         [0172]    Test 4—Instrumental Evaluation of the Effect of the Composition of the Invention (Called 13-39540-02) on the Erythema Caused by the Tape-Stripping Technique 
       4.1—Objective 
       [0173]      
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
             
           
               
                 TABLE 22 
               
             
             
               
                   
               
               
                 Measurements. descriptive statistics and results of the comparison 
               
             
          
           
               
                 Participant of 
                 13-39540-02 
                 Control 
                 13-39540-02 
                 Control 
               
             
          
           
               
                 the research 
                 Tb 
                 T0 
                 Tb 
                 T0 
                 Δ (T0 − Tb) 
                 Δ (T0 − Tb) 
               
               
                   
               
             
          
           
               
                 001 
                 318 
                 425 
                 334 
                 428 
                 107 
                 94 
               
               
                 002 
                 278 
                 391 
                 278 
                 401 
                 113 
                 123 
               
               
                 003 
                 211 
                 290 
                 207 
                 291 
                 79 
                 84 
               
               
                 004 
                 308 
                 436 
                 269 
                 396 
                 128 
                 127 
               
               
                 005 
                 348 
                 455 
                 334 
                 389 
                 107 
                 55 
               
               
                 006 
                 168 
                 326 
                 178 
                 334 
                 158 
                 156 
               
               
                 007 
                 326 
                 473 
                 342 
                 451 
                 147 
                 109 
               
               
                 008 
                 304 
                 379 
                 268 
                 393 
                 75 
                 125 
               
               
                 009 
                 317 
                 407 
                 339 
                 420 
                 90 
                 81 
               
               
                 010 
                 253 
                 383 
                 248 
                 391 
                 130 
                 143 
               
               
                 011 
                 279 
                 364 
                 238 
                 350 
                 85 
                 112 
               
               
                 012 
                 265 
                 379 
                 247 
                 361 
                 114 
                 114 
               
               
                 013 
                 318 
                 435 
                 304 
                 486 
                 117 
                 182 
               
               
                 014 
                 325 
                 418 
                 347 
                 436 
                 93 
                 89 
               
               
                 015 
                 233 
                 319 
                 225 
                 322 
                 86 
                 97 
               
               
                 016 
                 236 
                 349 
                 258 
                 368 
                 113 
                 110 
               
               
                 017 
                 232 
                 314 
                 234 
                 339 
                 82 
                 105 
               
               
                 018 
                 336 
                 447 
                 311 
                 406 
                 111 
                 95 
               
               
                 019 
                 227 
                 303 
                 231 
                 318 
                 76 
                 87 
               
               
                 020 
                 291 
                 395 
                 263 
                 372 
                 104 
                 109 
               
               
                 021 
                 318 
                 399 
                 292 
                 365 
                 81 
                 73 
               
               
                 Average 
                 280.5 
                 385.1 
                 273.7 
                 381.8 
                 104.6 
                 108.1 
               
               
                 Medium 
                 291.0 
                 391.0 
                 268.0 
                 389.0 
                 107.0 
                 109.0 
               
               
                 Minimum 
                 168.0 
                 290.0 
                 178.0 
                 291.0 
                 75.0 
                 55.0 
               
               
                 Maximum 
                 348.0 
                 473.0 
                 347.0 
                 486.0 
                 158.0 
                 182.0 
               
               
                 Standard error 
                 10.5 
                 11.5 
                 10.5 
                 10.4 
                 5.1 
                 6.3 
               
               
                 IC of 95% 
                 [259.5; 301.6] 
                 [362.1; 408.1] 
                 [252.6; 294.8] 
                 [360.9; 402.6] 
                 [94.4; 114.7] 
                 [95.5; 120.7] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 37.3 
                 39.5 
               
               
                 % of participants with irritaging effect 
                 100.0 
                 100.0 
               
               
                 P-Value 
                 &lt;0.001*** 
                 &lt;0.001*** 
               
               
                   
               
               
                 ***significant at level 0.1%; 
               
               
                 **significant at level 1%; 
               
               
                 *significant at level 5% (t-Student test). 
               
             
          
         
       
     
         [0174]    The T0 was higher on the average than the Tb for product and control 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 23 
               
               
                   
               
               
                 Measurements and descriptive statistics of the product 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ (T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Participant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 001 
                 425 
                 326 
                 358 
                 363 
                 396 
                 373 
                 372 
                 359 
                 −99 
               
               
                 002 
                 391 
                 246 
                 262 
                 292 
                 290 
                 292 
                 286 
                 294 
                 −145 
               
               
                 003 
                 290 
                 216 
                 193 
                 196 
                 213 
                 195 
                 192 
                 202 
                 −74 
               
               
                 004 
                 436 
                 313 
                 345 
                 386 
                 384 
                 378 
                 360 
                 396 
                 −123 
               
               
                 005 
                 455 
                 290 
                 301 
                 297 
                 303 
                 310 
                 336 
                 364 
                 −165 
               
               
                 006 
                 326 
                 162 
                 180 
                 180 
                 172 
                 228 
                 217 
                 215 
                 −164 
               
               
                 007 
                 473 
                 315 
                 337 
                 312 
                 325 
                 355 
                 327 
                 360 
                 −158 
               
               
                 008 
                 379 
                 280 
                 288 
                 294 
                 292 
                 299 
                 298 
                 307 
                 −99 
               
               
                 009 
                 407 
                 312 
                 324 
                 319 
                 326 
                 328 
                 337 
                 326 
                 −95 
               
               
                 010 
                 383 
                 274 
                 296 
                 304 
                 319 
                 324 
                 322 
                 301 
                 −109 
               
               
                 011 
                 364 
                 284 
                 271 
                 271 
                 281 
                 279 
                 289 
                 289 
                 −80 
               
               
                 012 
                 379 
                 228 
                 228 
                 260 
                 248 
                 269 
                 266 
                 273 
                 −151 
               
               
                 013 
                 435 
                 391 
                 390 
                 405 
                 408 
                 415 
                 415 
                 421 
                 −44 
               
               
                 014 
                 418 
                 370 
                 354 
                 372 
                 400 
                 383 
                 380 
                 399 
                 −48 
               
               
                 015 
                 319 
                 293 
                 281 
                 274 
                 290 
                 275 
                 281 
                 297 
                 −26 
               
               
                 016 
                 349 
                 201 
                 189 
                 219 
                 229 
                 247 
                 248 
                 282 
                 −148 
               
               
                 017 
                 314 
                 248 
                 238 
                 269 
                 272 
                 264 
                 270 
                 269 
                 −66 
               
               
                 018 
                 447 
                 333 
                 317 
                 338 
                 325 
                 339 
                 336 
                 389 
                 −114 
               
               
                 019 
                 303 
                 216 
                 209 
                 224 
                 243 
                 241 
                 253 
                 259 
                 −87 
               
               
                 020 
                 395 
                 313 
                 290 
                 299 
                 338 
                 304 
                 317 
                 336 
                 −82 
               
               
                 021 
                 399 
                 355 
                 347 
                 339 
                 386 
                 379 
                 353 
                 381 
                 −44 
               
               
                 Averate 
                 385.1 
                 284.1 
                 285.6 
                 295.9 
                 306.7 
                 308.4 
                 307.4 
                 320.0 
                 −101.0 
               
               
                 Medium 
                 391.0 
                 290.0 
                 290.0 
                 297.0 
                 303.0 
                 304.0 
                 317.0 
                 307.0 
                 −99.0 
               
               
                 Minimum 
                 290.0 
                 162.0 
                 180.0 
                 180.0 
                 172.0 
                 195.0 
                 192.0 
                 202.0 
                 −165.0 
               
               
                 Maximum 
                 473.0 
                 391.0 
                 390.0 
                 405.0 
                 408.0 
                 415.0 
                 415.0 
                 421.0 
                 −26.0 
               
               
                 Standard 
                 11.5 
                 12.8 
                 13.4 
                 13.1 
                 14.2 
                 12.7 
                 12.1 
                 13.2 
                 9.3 
               
               
                 error 
               
               
                 IC of 
                 [362.1; 
                 [258.5; 
                 [258.9; 
                 [269.6; 
                 [278.3; 
                 [282.9; 
                 [283.1; 
                 [293.5; 
                 [−119.7; 
               
               
                 95% 
                 408.1] 
                 309.7] 
                 312.3] 
                 322.1] 
                 335] 
                 333.9] 
                 331.6] 
                 346.4] 
                 −82.3] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 −26.2 
               
               
                   
               
             
          
           
               
                   
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                 Participant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
               
               
                 001 
                 −67 
                 −62 
                 −29 
                 −52 
                 −53 
                 −66 
               
               
                 002 
                 −129 
                 −99 
                 −101 
                 −99 
                 −105 
                 −97 
               
               
                 003 
                 −97 
                 −94 
                 −77 
                 −95 
                 −98 
                 −88 
               
               
                 004 
                 −91 
                 −50 
                 −52 
                 −58 
                 −76 
                 −40 
               
               
                 005 
                 −154 
                 −158 
                 −152 
                 −145 
                 −119 
                 −91 
               
               
                 006 
                 −146 
                 −146 
                 −154 
                 −98 
                 −109 
                 −111 
               
               
                 007 
                 −136 
                 −161 
                 −148 
                 −118 
                 −146 
                 −113 
               
               
                 008 
                 −91 
                 −85 
                 −87 
                 −80 
                 −81 
                 −72 
               
               
                 009 
                 −83 
                 −88 
                 −81 
                 −79 
                 −70 
                 −81 
               
               
                 010 
                 −87 
                 −79 
                 −64 
                 −59 
                 −61 
                 −82 
               
               
                 011 
                 −93 
                 −93 
                 −83 
                 −85 
                 −75 
                 −75 
               
               
                 012 
                 −151 
                 −119 
                 −131 
                 −110 
                 −113 
                 −106 
               
               
                 013 
                 −45 
                 −30 
                 −27 
                 −20 
                 −20 
                 −14 
               
               
                 014 
                 −64 
                 −46 
                 −18 
                 −35 
                 −38 
                 −19 
               
               
                 015 
                 −38 
                 −45 
                 −29 
                 −44 
                 −38 
                 −22 
               
               
                 016 
                 −160 
                 −130 
                 −120 
                 −102 
                 −101 
                 −67 
               
               
                 017 
                 −76 
                 −45 
                 −42 
                 −50 
                 −44 
                 −45 
               
               
                 018 
                 −130 
                 −109 
                 −122 
                 −108 
                 −111 
                 −58 
               
               
                 019 
                 −94 
                 −79 
                 −60 
                 −62 
                 −50 
                 −44 
               
               
                 020 
                 −105 
                 −96 
                 −57 
                 −91 
                 −78 
                 −59 
               
               
                 021 
                 −52 
                 −60 
                 −13 
                 −20 
                 −46 
                 −18 
               
               
                 Averate 
                 −99.5 
                 −89.2 
                 −78.4 
                 −76.7 
                 −77.7 
                 −65.1 
               
               
                 Medium 
                 −93.0 
                 −88.0 
                 −77.0 
                 −80.0 
                 −76.0 
                 −67.0 
               
               
                 Minimum 
                 −160.0 
                 −161.0 
                 −154.0 
                 −145.0 
                 −146.0 
                 −113.0 
               
               
                 Maximum 
                 −38.0 
                 −30.0 
                 −13.0 
                 −20.0 
                 −20.0 
                 −14.0 
               
               
                 Standard 
                 8.0 
                 8.3 
                 9.9 
                 7.3 
                 7.2 
                 6.8 
               
               
                 error 
               
               
                 IC of 
                 [−115.6; 
                 [−105.8; 
                 [−98.3; −58.6] 
                 [−91.2; −62.2] 
                 [−92.1; 
                 [−78.7; −51.6] 
               
               
                 95% 
                 −83.4] 
                 −72.7] 
                   
                   
                 −63.3] 
               
               
                 Δ (%) with 
                 −25.8 
                 −23.2 
                 −20.4 
                 −19.9 
                 −20.2 
                 −16.9 
               
               
                 respect to the 
               
               
                 T0 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 24 
               
               
                   
               
               
                 Measurements and descriptive statistics of the control 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ (T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Participant 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 001 
                 428 
                 340 
                 351 
                 382 
                 381 
                 384 
                 357 
                 379 
                 −88 
               
               
                 002 
                 401 
                 326 
                 329 
                 337 
                 338 
                 323 
                 333 
                 331 
                 −75 
               
               
                 003 
                 291 
                 245 
                 243 
                 250 
                 249 
                 246 
                 241 
                 234 
                 −46 
               
               
                 004 
                 396 
                 283 
                 315 
                 339 
                 360 
                 352 
                 343 
                 369 
                 −113 
               
               
                 005 
                 389 
                 325 
                 324 
                 331 
                 319 
                 333 
                 349 
                 344 
                 −64 
               
               
                 006 
                 334 
                 180 
                 229 
                 203 
                 214 
                 248 
                 251 
                 260 
                 −154 
               
               
                 007 
                 451 
                 323 
                 360 
                 337 
                 349 
                 382 
                 307 
                 348 
                 −128 
               
               
                 008 
                 393 
                 288 
                 296 
                 308 
                 292 
                 294 
                 287 
                 321 
                 −105 
               
               
                 009 
                 420 
                 361 
                 343 
                 348 
                 368 
                 365 
                 398 
                 383 
                 −59 
               
               
                 010 
                 391 
                 281 
                 306 
                 325 
                 326 
                 325 
                 323 
                 343 
                 −110 
               
               
                 011 
                 350 
                 268 
                 267 
                 262 
                 285 
                 293 
                 306 
                 310 
                 −82 
               
               
                 012 
                 361 
                 270 
                 292 
                 261 
                 312 
                 282 
                 287 
                 301 
                 −91 
               
               
                 013 
                 486 
                 366 
                 377 
                 388 
                 385 
                 399 
                 392 
                 408 
                 −120 
               
               
                 014 
                 436 
                 396 
                 397 
                 412 
                 421 
                 416 
                 432 
                 419 
                 −40 
               
               
                 015 
                 322 
                 270 
                 277 
                 262 
                 267 
                 275 
                 296 
                 294 
                 −52 
               
               
                 016 
                 368 
                 244 
                 222 
                 241 
                 248 
                 264 
                 262 
                 301 
                 −124 
               
               
                 017 
                 339 
                 288 
                 293 
                 310 
                 303 
                 301 
                 305 
                 296 
                 −51 
               
               
                 018 
                 406 
                 319 
                 313 
                 318 
                 312 
                 344 
                 316 
                 338 
                 −87 
               
               
                 019 
                 318 
                 245 
                 225 
                 256 
                 260 
                 260 
                 270 
                 276 
                 −73 
               
               
                 020 
                 372 
                 293 
                 290 
                 279 
                 331 
                 316 
                 348 
                 357 
                 −79 
               
               
                 021 
                 365 
                 305 
                 296 
                 278 
                 308 
                 313 
                 329 
                 316 
                 −60 
               
               
                 Average 
                 381.8 
                 296.0 
                 302.1 
                 306.0 
                 315.6 
                 319.8 
                 320.6 
                 329.9 
                 −85.8 
               
               
                 Medium 
                 389.0 
                 288.0 
                 296.0 
                 310.0 
                 312.0 
                 316.0 
                 316.0 
                 331.0 
                 −82.0 
               
               
                 Minimum 
                 291.0 
                 180.0 
                 222.0 
                 203.0 
                 214.0 
                 246.0 
                 241.0 
                 234.0 
                 −154.0 
               
               
                 Maximum 
                 486.0 
                 396.0 
                 397.0 
                 412.0 
                 421.0 
                 416.0 
                 432.0 
                 419.0 
                 −40.0 
               
               
                 Standard 
                 10.4 
                 10.7 
                 10.6 
                 11.7 
                 11.3 
                 10.9 
                 10.7 
                 10.2 
                 6.7 
               
               
                 error 
               
               
                 IC of 
                 [360.9; 
                 [274.6; 
                 [281; 
                 [282.6; 
                 [293.1; 
                 [298; 
                 [299.2; 
                 [309.4; 
                 [−99.2; 
               
               
                 95% 
                 402.6] 
                 317.4] 
                 323.3] 
                 329.5] 
                 338.2] 
                 341.6] 
                 341.9] 
                 350.4] 
                 −72.3] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 −22.5 
               
               
                   
               
             
          
           
               
                   
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                 Participant 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
               
               
                 001 
                 −77 
                 −46 
                 −47 
                 −44 
                 −71 
                 −49 
               
               
                 002 
                 −72 
                 −64 
                 −63 
                 −78 
                 −68 
                 −70 
               
               
                 003 
                 −48 
                 −41 
                 −42 
                 −45 
                 −50 
                 −57 
               
               
                 004 
                 −81 
                 −57 
                 −36 
                 −44 
                 −53 
                 −27 
               
               
                 005 
                 −65 
                 −58 
                 −70 
                 −56 
                 −40 
                 −45 
               
               
                 006 
                 −105 
                 −131 
                 −120 
                 −86 
                 −83 
                 −74 
               
               
                 007 
                 −91 
                 −114 
                 −102 
                 −69 
                 −144 
                 −103 
               
               
                 008 
                 −97 
                 −85 
                 −101 
                 −99 
                 −106 
                 −72 
               
               
                 009 
                 −77 
                 −72 
                 −52 
                 −55 
                 −22 
                 −37 
               
               
                 010 
                 −85 
                 −66 
                 −65 
                 −66 
                 −68 
                 −48 
               
               
                 011 
                 −83 
                 −88 
                 −65 
                 −57 
                 −44 
                 −40 
               
               
                 012 
                 −69 
                 −100 
                 −49 
                 −79 
                 −74 
                 −60 
               
               
                 013 
                 −109 
                 −98 
                 −101 
                 −87 
                 −94 
                 −78 
               
               
                 014 
                 −39 
                 −24 
                 −15 
                 −20 
                 −4 
                 −17 
               
               
                 015 
                 −45 
                 −60 
                 −55 
                 −47 
                 −26 
                 −28 
               
               
                 016 
                 −146 
                 −127 
                 −120 
                 −104 
                 −106 
                 −67 
               
               
                 017 
                 −46 
                 −29 
                 −36 
                 −38 
                 −34 
                 −43 
               
               
                 018 
                 −93 
                 −88 
                 −94 
                 −62 
                 −90 
                 −68 
               
               
                 019 
                 −93 
                 −62 
                 −58 
                 −58 
                 −48 
                 −42 
               
               
                 020 
                 −82 
                 −93 
                 −41 
                 −56 
                 −24 
                 −15 
               
               
                 021 
                 −69 
                 −87 
                 −57 
                 −52 
                 −36 
                 −49 
               
               
                 Average 
                 −79.6 
                 −75.7 
                 −66.1 
                 −62.0 
                 −61.2 
                 −51.9 
               
               
                 Medium 
                 −81.0 
                 −72.0 
                 −58.0 
                 −57.0 
                 −53.0 
                 −49.0 
               
               
                 Minimum 
                 −146.0 
                 −131.0 
                 −120.0 
                 −104.0 
                 −144.0 
                 −103.0 
               
               
                 Maximum 
                 −39.0 
                 −24.0 
                 −15.0 
                 −20.0 
                 −4.0 
                 −15.0 
               
               
                 Standard 
                 5.4 
                 6.4 
                 6.4 
                 4.6 
                 7.5 
                 4.8 
               
               
                 error 
               
               
                 IC of 
                 [−90.4; 
                 [−88.6; 
                 [−78.9; −53.4] 
                 [−71.1; −52.9] 
                 [−76.2; 
                 [−61.4; −42.4] 
               
               
                 95% 
                 −68.8] 
                 −62.9] 
                   
                   
                 −46.2] 
               
               
                 Δ (%) with 
                 −20.9 
                 −19.8 
                 −17.3 
                 −16.2 
                 −16.0 
                 −13.6 
               
               
                 respect to the 
               
               
                 T0 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 25 
               
             
             
               
                   
               
               
                 Average and standard error of each treatment per time, 
               
               
                 and of the difference between the treatments 
               
             
          
           
               
                   
                 Producut 
                 Control 
                 Product − Control 
               
             
          
           
               
                 Time 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
               
               
                   
               
             
          
           
               
                 T0 
                 385.10 
                 11.50 
                 381.76 
                 10.42 
                 3.33 
                 5.94 
               
               
                 T30 min 
                 284.10 
                 12.78 
                 296.00 
                 10.71 
                 −11.90 
                 7.02 
               
               
                 T1 h 
                 285.62 
                 13.35 
                 302.14 
                 10.58 
                 −16.52 
                 6.78 
               
               
                 T2 h 
                 295.86 
                 13.13 
                 306.05 
                 11.70 
                 −10.19 
                 6.72 
               
               
                 T3 h 
                 306.67 
                 14.18 
                 315.62 
                 11.28 
                 −8.95 
                 7.01 
               
               
                 T4 h 
                 308.43 
                 12.74 
                 319.76 
                 10.90 
                 −11.33 
                 5.56 
               
               
                 T5 h 
                 307.38 
                 12.12 
                 320.57 
                 10.67 
                 −13.19 
                 5.95 
               
               
                 T6 h 
                 319.95 
                 13.24 
                 329.90 
                 10.24 
                 −9.95 
                 6.84 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
             
               
               
               
               
             
               
               
               
               
               
             
           
               
                 TABLE 26 
               
             
             
               
                   
               
               
                 Porcentage of variation in the average with respect to the time T0, 
               
               
                 and percentage of participants with positive and negative effect 
               
             
          
           
               
                   
                 Product - Control 
               
             
          
           
               
                   
                 % of variation 
                 % of participants 
                 % of participants 
               
               
                   
                 with respect 
                 with positive 
                 with negative 
               
             
          
           
               
                 Time 
                 to the T0 
                 effect 
                 effect 
               
               
                   
               
             
          
           
               
                 T30 
                 min 
                 −3.8 
                 71.4 
                 28.6 
               
               
                 T1 
                 h 
                 −5.0 
                 76.2 
                 23.8 
               
               
                 T2 
                 h 
                 −3.3 
                 76.2 
                 19.0 
               
               
                 T3 
                 h 
                 −3.0 
                 66.7 
                 28.6 
               
               
                 T4 
                 h 
                 −3.7 
                 71.4 
                 28.6 
               
               
                 T5 
                 h 
                 −4.2 
                 76.2 
                 23.8 
               
               
                 T6 
                 h 
                 −3.3 
                 71.4 
                 19.0 
               
               
                   
               
             
          
         
       
     
         [0175]    The product exhibited greater reduction with respect to the T0 in the average values of erythema compared with the control in the times T30min (p-value=0.0416), T1h (p-value=0.0040), and T5h (p-value=0.332). No significant differences were found between product and control in the times T2h (p-value=0.0579), T3h (p-value=0.1489). T4h (p-value 0.0712), and T6h (p-value=0.0508). 
         [0176]    The times T30, T1h, T2h, T3h, T4h, T5h and T6h were lower than the time T0 for the product (p-values&lt;0.001). 
       Wherein: 
       [0177]    Cm 2 : square centigrade:
 
G: grams;
 
H: hours;
 
No.: number;
 
° C.=degrees Celsius;
 
Tx: Time after x hours of application of the product.
 
       6.5—Conclusion 
       [0000]    
       
         
           
             After a statistical analysis of the results, one can conclude that the composition of the invention promoted reduction of the erythema caused by the tape-stripping technique until the time of 1 hour and in the time of 5 hours. 
           
         
       
     
         [0179]    Test 5—Evaluation of the Reduction of Erythema Caused by the Tape-Stripping Technique by Using the Composition of the Invention (called NT1123-12-A). 
       5.1 Objective 
       [0180]    Evaluating the efficacy of the topical product (called BDP 1160.18704.6) referring to a composition according to the in reducing skin erythema induced by mechanical insult and evaluated as a function of the redness of the skin. Ion this study, one evaluated the efficacy of a composition according to the invention (NT1123-12-A) in reducing cutaneous erythema with respect to a control (site without application of any products). The evaluations were carried in the following times: 
         [0181]    t0: right after formation of the erythema induced by the tape-stripping method; 
         [0182]    t0.5: 30 minutes after induction of the erythema and application or non-application of the product; 
         [0183]    t1: 1 hour after induction of the erythema and application or non-application of the product; 
         [0184]    t2: 2 hours after induction of the erythema and application or non-application of the product; 
         [0185]    t3: 3 hours after induction of the erythema and application or non-application of the product; 
         [0186]    t4: 4 hours after induction of the erythema and application or non-application of the product; 
         [0187]    t5: 5 hours after induction of the erythema and application or non-application of the product. 
       5.2—Methodology, Materials and Equipment 
       [0188]    On each voluntary woman (a total of 25 participants), two 2.5×4.0 cm rectangles were marked with a surgical pen, called sites, on the left or right forearm. After 30 minutes of air-conditioning, the environment controlled at 20±° C. and 50±5% of relative humidity of the air, 30 tape-stripping removals with Transpore® 3M tape were carried out at each site, followed by the measurements of erythema by the mexametry and colorimetry technique. These measurements were called basal measurements (t0). After the mechanical insult, the product was applied, and the voluntary women remained at the laboratory for the measurements after 0.5 (30 minutes), 1, 2, 3, 4, 5 and 6 hours. During the whole experiment the climatic conditions were kept constant according to the ranges cited before. At the site intended for the product, 80 μL of the sample under study was applied, one of the sites being used as control (without application of any products). 
       5.3—Acquisition of Measurements 
       [0189]    The measurements were made by using a Mexameter® MX 18 probe, coupled to the equipment Multi Probe Adapter MPA-5 (CKeletronics, Germany). Concomitantly with the measurements, one used an automatized spreadsheet of the software Microsoft® Office Excel 2010 for calculation of the Variation Coefficient (VC/CV) of the readings obtained. One carried out 5 measurements per site in each time. If in 5 measurements the VC/CV presented a value lower than 4%, one would finish the measurements at the site and continue them in the next one; otherwise, the process was restarted by using the colorimeter Byk-Gardner Spectro-Guide Sphere Gloss. For this evaluation, one recorded only the values of a*, which is the axis that ranges from green (−120) to read (+120). The values were recorded on an automatized spreadsheet of the software Microsoft® Office Excel 2010 for calculation of the Coefficient of Variation (CV/VC) of the readings obtained. One carried out 3 measurements per site in each time. If in 3 measurements the CV/VC presented a value lower than 4%, one would finish the measurements at the site and continue the measurements at the next one; otherwise the process was restarted until a CV/VC lower than 4% would be obtained. 
       5.4—Results 
     5.4.1—Evaluation of the Reduction of the Erythema by Mexametry 
       [0190]    In evaluating of the reduction of the erythema by mexametry, one measured the erythema values (E) for each voluntary woman, at the site intended for the product and at the control site.  FIG. 13  shows the average values of Erythema (E) obtained for the product site and control site. 
         [0191]    In order to evaluate the homogeneity of t erythema caused by the mechanical insult, the values of erythema measured at each site in the basal time (t0) were statistically compared with each other by using the t-Student test, in pairs, with trust interval of 95%. The result is summarized in Table 27. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                 TABLE 27 
               
               
                   
               
               
                 Comparison of the values of erythema induced 
               
               
                 after mechanical insult - Value of P. 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 E t0  product vs. E t0  control 
                 0.5533 (non-significant) 
               
               
                   
                   
               
             
          
         
       
     
         [0192]    According to the results obtained, there was no statistically significant difference between the sites (P&gt;0.05), indicating the homogeneity in the values of erythema after the mechanical insult. This indicated that the study was conducted with homogeneous basal values of erythema at the evaluation sites. 
         [0193]    In order to evaluate whether there were significant variations in the erythema along the study, the erythema measurements obtained after 0.5; 1; 2; 3; 4; 5 and 6 hours from application of the product, or the basal measurements (t0) were not compared, carried out right after the mechanical insult (prior to application of the product), by using the single-factor variance analysis method, with Dunnett post-test multiple comparison, considering α=0.05. The results of the statistical analysis are summarized in Table 28. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                 TABLE 28 
               
             
             
               
                   
               
               
                 Summarized data of the statistical analysis. Comparison of the values 
               
               
                 of erythema formed after the mechanical insult (t0) vs ti (wherein 
               
               
                 i = 0.5, 1, 2, 3, 4, 5 and 6 hours from application). P values 
               
             
          
           
               
                 Comparison group 
                 Control 
                 NT1123-12-A 
               
               
                   
               
               
                 E t0  vs. E t0.5   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 E t0  vs. E t1   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 E t0  vs. E t2   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 E t0  vs. E t3   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 E t0  vs. E t4   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 E t0  vs. E t5   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 E t0  vs. E t6   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                   
               
             
          
         
       
     
         [0194]    According to the results, it was possible to find out that there was a statistically significant reduction (P&lt;0.05) of the skin erythema after 0.5, 1, 2, 3, 4, 5 and h hours from application of the composition according to the invention as compared with the initial erythema (t0) and still that at the control site (without application of any products) was also obtained one observed a significant reduction (P&lt;0.05) in the erythema formed by the mechanical insult after 0.5, 1, 2, 3, 4, 5 and 6 hours. 
         [0195]    Although one has observed a reduction of the erythema at both sites along the study, it is possible to observe, in  FIG. 14 , which shows the percentage of Reduction of the Erythema (% RE) obtained in each evaluation time, what there was a more marked reduction of the erythema at the site intended for the product. 
         [0196]    In order to evaluate the significance of the reduction of the erythema along the time, that is, the Calming Effect (EC/CE) provided by the product with respect to the control, one calculated the ratio between the erythema measurements after 0.5, 1, 2, 3, 4, 5 and 6 hours with respect to the value obtained right after the mechanical insult (t0), by using Equation 1. 
         [0000]    
       
      
       EC=E 
       ti 
       /E 
       t0  
      
     
         [0197]    Equation 1. Calculation of the Calming Effect (EC). E ti =measurement of the coloration of the erythema in the time i (i=0.5, 1, 2, 3, 4, 5 and 6h) and E t0 =measurement of the coloration of the basal erythema (right after formation). 
         [0198]    The values of the Calming Effect obtained for the site with application of the product, in each time, were statistically compared with the values obtained for the control by using the t-Student test, bimodal, in pairs, with trust interval of 95%. The results of the statistical analysis are listed in Attachment VII and are summarized in Table 29. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 29 
               
             
             
               
                   
               
               
                 Comparison of the results in terms of EC between the product and the respective control. 
               
               
                 P. values 
               
             
          
           
               
                 Comparison 
                   
                   
                   
                   
                   
                   
                   
               
               
                 group 
                 t0.5 
                 t1 
                 t2 
                 t3 
                 t4 
                 t5 
                 t6 
               
               
                   
               
               
                 EC NT1123-12-A   
                 0.0014 
                 0.0281 
                 0.0563 
                 0.0787 
                 0.0528 
                 0.1682 
                 0.6979 
               
               
                 vs. EC Control   
                 (significant) 
                 (significant) 
                 (Non- 
                 (Non- 
                 (Non- 
                 (Non- 
                 (Non- 
               
               
                   
                   
                   
                 significant) 
                 significant) 
                 significant) 
                 significant) 
                 significant) 
               
               
                   
               
             
          
         
       
     
         [0199]    The reduction of the skin erythema provided by the composition of the invention presented a statistically significant difference (P&lt;0.05) after 30 minutes and 1 hour from application as compared with the respective control (site without application of any products). This indicated that the product was effective in reducing skin erythema by mechanical insult and evaluated as a function of the redness of the skin until 1 hour after application. 
       5.4.2—Evaluation of the Reduction of the Erythema by Colorimetry 
       [0200]    In evaluating the reduction of the erythema by colorimetry, one measured the values of the coordinate *a for each volunteer at the site intended for the product and at the control site.  FIG. 15  shows the average value of the Erythema Intensity (+a*). 
         [0201]    In order to evaluate the homogeneity of the erythema formed by the mechanical insult, the values of a* measured at each site in the basal time (t0) were statistically compared by using the t-Student test, in pairs, with trust interval of 95%. The results achieved are summarized in table 30. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                 TABLE 30 
               
               
                   
               
               
                 Comparison of the values of the erythema occurrences 
               
               
                 induced after mechanical insult. Value of P 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                 a*t0 product vs. a* t0 control 
                 0.6682 (non-significant) 
               
               
                   
                   
               
             
          
         
       
     
         [0202]    According to the results obtained, there was no statistically significant difference between the sites (P&gt;0.05), indicating that there was homogeneity in the values of a* after the mechanical insult. This indicated that the study was conducted with homogeneous basal erythema values for the sites under evaluation. 
         [0203]    In order to evaluate whether there were significant alterations in the erythema along the study, the erythema measurements obtained after 0.5, 1, 2, 3, 4, 5, and 6 hours from application of the product or non-application were compared with the basal measurements (t0) carried out right after the mechanical insult (prior to application of the product), by using the single-factor variance analysis, with post-test of Dunnett multiple comparison, considering α=0.0.05. The results of the statistical analysis are summarized in Table 31. 
         [0000]    
       
         
               
             
               
               
               
             
           
               
                 TABLE 31 
               
             
             
               
                   
               
               
                 Summarized data of the statistical analysis. Comparison of the values 
               
               
                 of a* obtained after the mechanical insult (t0) vs. ti (wherein i = 
               
               
                 0.5, 1, 2, 3, 4, 5 e 6 h from application), Values of P. 
               
             
          
           
               
                 Comparison group 
                 Control 
                 NT1123-12-A 
               
               
                   
               
               
                 a* t0  vs. a* t0.5   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 a* t0  vs. a* t1   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 a* t0  vs. a* t2   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 a* t0  vs. a* t3   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 a* t0  vs. a* t4   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 a* t0  vs. a* t5   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                 a* t0  vs. a* t6   
                 P &lt; 0.05 (significant) 
                 P &lt; 0.05 (significant) 
               
               
                   
               
             
          
         
       
     
         [0204]    According to the results, it was possible to observe that that was a statistically significant reduction (P&lt;0.05) of the skin erythema after 0.5, 1, 2, 3, 4, 5, and 6 hours from application of the composition according to the invention as compared with the initial erythema (t0), and that in the control site (without application of any products) there was a significant reduction (P&lt;0.05) in the erythema formed by the mechanical insult after 0.5, 1, 2, 3, 45, and 6 hours. Although there has been a reduction of the erythema at both sites along the study, it is possible to observe, in  FIG. 16 , which shows the percentage of Reduction of Erythema Intensity (% RIE) obtained in each evaluation time, that there was a greater reduction of the erythema at the site intended for the product. 
         [0205]    In order to evaluate the Calming Effect (CE/EC), one calculated the ratio between the measurements of a* after 0.5, 1, 2, 3, 4, 5, and 6 hours with respect to the value obtained along the mechanical insult (t0), by using Equation 2. 
         [0000]    
       
      
       EC=a* 
       ti 
       /a* 
       t0  
      
     
         [0000]    Equation 2—Calculation of the Calming Effect (EC). a* ti =measurement of the coloration of the erythema in the time i (i=0.5, 1, 2, 3, 4, 5 e 6h) e a* t0 =measurement of the coloration of the basal erythema (right after formation) 
         [0206]    The values of the Calming Effect achieved for the site with application of the product, in each time, were statistically compared with the values achieved for the control by using the t-Student test, bimodal, in pairs, with trust interval of 95%. The results of the statistical analysis are summarized in table 32. 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
             
           
               
                 TABLE 32 
               
             
             
               
                   
               
               
                 A comparison of the results in terms of EC between the product and the 
               
               
                 respective control. Values of P. 
               
             
          
           
               
                 Comparison 
                   
                   
                   
                   
                   
                   
                   
               
               
                 group 
                 t0.5 
                 t1 
                 t2 
                 t3 
                 t4 
                 t5 
                 t6 
               
               
                   
               
               
                 EC NT1123-12-A   
                 0.0358 
                 0.0280 
                 0.5951 
                 0.4005 
                 0.5370 
                 0.7799 
                 0.6547 
               
               
                 vs. EC Controle   
                 (significant) 
                 (significant) 
                 (non- 
                 (non- 
                 (non- 
                 (non- 
                 (non- 
               
               
                   
                   
                   
                 sitnificant) 
                 significant) 
                 significant) 
                 significant) 
                 significant) 
               
               
                   
               
             
          
         
       
     
         [0207]    The reduction of the skin erythema provided by the composition according to the invention shows a statistically significant difference (P&lt;0.05) after 30 minutes and 1 hour from application as compared with the respective control (site without application of any products). This indicated that the product was effective in reducing the skin erythema induced by mechanical insult and evaluated as a function of the skin redness until 1 hour from application. 
         [0208]    Test 6—Instrumental Test of the Effect of the Composition of the Invention (Called 12-33171-07) on the Erythema Caused by the Tape-Stripping Technique 
       6.1—Objective 
       [0209]    Evaluating the potential of calming action of a topical product referring to a composition according to the invention through instrumental measurements of colorimetry. 
         [0000]    6.2—Methodology. Materials and Equipment 
         [0210]    Two symmetrical 10 cm 2  areas having randomized distribution in the front region of the forearms of the patients (a total of 19 participants) were demarcated. One of the areas was used for application of the product and the other was kept as control (untreated area). Colorimetric measurements were made with the equipment Mexameter MX18-Courage+Khazaka prior to tape-stripping removal (Fita Hipoalergênica Transproe MR ) and application of the product (Tb) after 30 tape-stripping removals at each site (T0) and after 30 minutes, 1, 2, 3, 4, 5 and 6 hours from application of the product. 
       6.3—Measurement of Erythema-Mexametry 
       [0211]    The measurements were carried out by using the equipment Mexameter MX 18, Courage+Khazaka electronic GmbH through a measurement probe. The readings were made by applying the probe to the test areas with the pressure permitted by the spring (0.5 N). 
         [0212]    The measurement area was 5 mm in diameter. Three measurements were carried out in each area. The measurement consisted in measuring the light absorbed and reflected at the wavelengths for green and red for hemoglobin and wavelengths for green and near infrared for melanin. 
         [0213]    The operator positioned the probe vertically, forming a 90-degree angle with the skin and cleaned the probe with the aid of a very soft piece of paper prior to the first reading and between the readings of one area an another, even if it were the control area or the initial measurement of each area. 
         [0214]    The reading indicated the degree of erythema of the skin. The scale of the equipment is arbitrary, the reading values indicating greater redness of the skin (erythema). 
       6.4—Steps of Research 
     6.4.1—First Step 
       [0000]    
       
         
           
             The participants remained at rest in an air-conditioned room with temperature of 20±2° C. and relative humidity of 50±5% for at least 30 minutes prior to each reading; 
             The participants were told not to smoke; not to come out of the test room without prior authorization of the expert; not to come into contact with the area being tested at any place; not to contact the area being tested in contact with the clothes between the first air-conditioning and the end of the measurements; not to make abrupt movements with any part of the body; and not to allow the test area to get wet 
             The participants were evaluated by the dermatologist to confirm the research inclusion criteria; 
             Two symmetric 10 cm 2  areas of the region before the forearms having randomized distribution were demarcated. One area was used for application of the product and the other area was kept as negative control (untreated area); and 
             One determined the coloration of the areas through arithmetic mean of three measurements (Tb). 
           
         
       
     
       6.4.2—Second Step 
       [0000]    
       
         
           
             30 tape-stripping removals were carried out in the two demarcated areas. The adhesive tapes (TransporeMR) were replaced at each removal; and 
             One determined the coloration of the demarcated areas through the arithmetic mean of three measurements (T0). 
           
         
       
     
       6.4.3—Third Step 
       [0000]    
       
         
           
             The tested product was applied in a randomized manner, in the amount of 0.02 g in the demarcated region of each participant. The product was spread over the skin with the aid of a latex fingerstall, with light and circular movements until the whole application area was entirely covered and homogeneous. The latex fingerstall was changed in each area; 
             The measurements were carried out in the following times: 
             T30min—thirty minutes after application of the product 
             T1h—one hour after application of the product 
             T2h—two hours after application of the product 
             T3h—three hours after application of the product; 
             T4h—four hours after application of the product; 
             T5h—five hours after application of the product; 
             T6h—six hours after application of the product. 
             The participants were evaluated by the dermatologist at the end of the measurements T6h; and 
             After the medical evaluation the participants were released. 
           
         
       
     
       6.5—Statistical Analysis 
       [0233]    The software used in the analyses was MINITAB 14 AND XLSTAT 2012. 
         [0234]    As said before, the number of participants in the research was 19 
         [0235]    The trust level considered in the comparative analysis was of 95%. 
       6.6—Results 
     6.6.1—Erythema Measurement-Mexametry 
       [0236]      
         [0000]    
       
         
               
             
               
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
             
           
               
                 TABLE 33 
               
             
             
               
                   
               
               
                 Measurements descriptive statistics and results of the comparison 
               
             
          
           
               
                   
                 12-33171-07 
                 Control 
                 12-33171-07 
                 Control 
               
             
          
           
               
                 Subject 
                 Tb 
                 T0 
                 Tb 
                 T0 
                 Δ (T0 − Tb) 
                 Δ (T0 − Tb) 
               
               
                   
               
             
          
           
               
                 002 
                 222 
                 325 
                 224 
                 291 
                 103 
                 67 
               
               
                 004 
                 262 
                 293 
                 264 
                 322 
                 31 
                 58 
               
               
                 005 
                 173 
                 291 
                 198 
                 256 
                 118 
                 58 
               
               
                 006 
                 255 
                 346 
                 267 
                 323 
                 91 
                 56 
               
               
                 007 
                 147 
                 346 
                 174 
                 213 
                 199 
                 39 
               
               
                 008 
                 238 
                 369 
                 246 
                 338 
                 131 
                 92 
               
               
                 009 
                 209 
                 258 
                 209 
                 334 
                 49 
                 125 
               
               
                 010 
                 157 
                 266 
                 192 
                 172 
                 109 
                 −20 
               
               
                 012 
                 187 
                 269 
                 162 
                 285 
                 82 
                 123 
               
               
                 013 
                 328 
                 383 
                 340 
                 364 
                 55 
                 24 
               
               
                 014 
                 163 
                 264 
                 117 
                 258 
                 101 
                 141 
               
               
                 015 
                 137 
                 304 
                 163 
                 236 
                 167 
                 73 
               
               
                 016 
                 155 
                 293 
                 135 
                 351 
                 138 
                 216 
               
               
                 017 
                 205 
                 363 
                 193 
                 397 
                 158 
                 204 
               
               
                 018 
                 279 
                 413 
                 271 
                 368 
                 134 
                 97 
               
               
                 019 
                 244 
                 380 
                 227 
                 374 
                 136 
                 147 
               
               
                 020 
                 208 
                 308 
                 243 
                 319 
                 100 
                 76 
               
               
                 021 
                 212 
                 287 
                 229 
                 313 
                 75 
                 84 
               
               
                 022 
                 293 
                 374 
                 330 
                 382 
                 81 
                 52 
               
               
                 Average 
                 214.4 
                 322.7 
                 220.2 
                 310.3 
                 108.3 
                 90.1 
               
               
                 Medium 
                 209.0 
                 308.0 
                 224.0 
                 322.0 
                 103.0 
                 76.0 
               
               
                 Minimum 
                 137.0 
                 258.0 
                 117.0 
                 172.0 
                 31.0 
                 −20.0 
               
               
                 Maximum 
                 328.0 
                 413.0 
                 340.0 
                 397.0 
                 199.0 
                 216.0 
               
               
                 Standard erros 
                 12.2 
                 10.9 
                 13.6 
                 14.0 
                 9.7 
                 13.4 
               
               
                 IC of 95% 
                 [189.9; 
                 [300.9; 
                 [193; 247.4] 
                 [282.3; 
                 [88.9; 127.8] 
                 [63.2; 117] 
               
               
                   
                 238.9] 
                 344.6] 
                   
                 338.3] 
               
             
          
           
               
                 Δ (%) with respect to the T0 
                 50.5 
                 40.9 
               
               
                 % of volunteers with irritating effect 
                 100.0 
                 94.7 
               
               
                 P-Value 
                 &lt;0.001*** 
                 &lt;0.001*** 
               
               
                   
               
               
                 ***significant at level 0.1%; 
               
               
                 **significant at level 1%; 
               
               
                 *significant at level 5% (t-Student test). 
               
             
          
         
       
     
         [0237]    The time T0 was higher on the average than the time Tb for product and control 
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 34 
               
               
                   
               
               
                 Measurements and descriptive statistics of the product 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ (T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Subject 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 002 
                 325 
                 214 
                 210 
                 204 
                 224 
                 248 
                 248 
                 227 
                 −111 
               
               
                 004 
                 293 
                 323 
                 320 
                 284 
                 309 
                 296 
                 280 
                 311 
                 30 
               
               
                 005 
                 291 
                 198 
                 191 
                 194 
                 191 
                 207 
                 203 
                 213 
                 −93 
               
               
                 006 
                 346 
                 289 
                 232 
                 259 
                 243 
                 262 
                 240 
                 245 
                 −57 
               
               
                 007 
                 346 
                 209 
                 202 
                 220 
                 269 
                 208 
                 251 
                 277 
                 −137 
               
               
                 008 
                 369 
                 278 
                 269 
                 267 
                 266 
                 250 
                 264 
                 242 
                 −91 
               
               
                 009 
                 258 
                 235 
                 192 
                 187 
                 190 
                 186 
                 228 
                 182 
                 −23 
               
               
                 010 
                 266 
                 193 
                 190 
                 229 
                 225 
                 227 
                 231 
                 233 
                 −73 
               
               
                 012 
                 269 
                 245 
                 212 
                 211 
                 209 
                 226 
                 302 
                 265 
                 −24 
               
               
                 013 
                 383 
                 276 
                 319 
                 325 
                 320 
                 305 
                 336 
                 350 
                 −107 
               
               
                 014 
                 264 
                 149 
                 157 
                 176 
                 178 
                 185 
                 195 
                 195 
                 −115 
               
               
                 015 
                 304 
                 200 
                 214 
                 191 
                 194 
                 204 
                 214 
                 244 
                 −104 
               
               
                 016 
                 293 
                 229 
                 192 
                 188 
                 183 
                 207 
                 249 
                 265 
                 −64 
               
               
                 017 
                 363 
                 225 
                 191 
                 255 
                 206 
                 248 
                 260 
                 249 
                 −138 
               
               
                 018 
                 413 
                 345 
                 311 
                 359 
                 325 
                 336 
                 366 
                 347 
                 −68 
               
               
                 019 
                 380 
                 335 
                 312 
                 267 
                 255 
                 316 
                 287 
                 308 
                 −45 
               
               
                 020 
                 308 
                 230 
                 241 
                 226 
                 166 
                 247 
                 254 
                 231 
                 −78 
               
               
                 021 
                 287 
                 191 
                 194 
                 196 
                 176 
                 197 
                 190 
                 225 
                 −96 
               
               
                 022 
                 374 
                 340 
                 335 
                 310 
                 328 
                 316 
                 288 
                 290 
                 −34 
               
               
                 Average 
                 322.7 
                 247.6 
                 236.0 
                 239.4 
                 234.6 
                 245.8 
                 257.2 
                 257.8 
                 −75.2 
               
               
                 Medium 
                 308.0 
                 230.0 
                 212.0 
                 226.0 
                 224.0 
                 247.0 
                 251.0 
                 245.0 
                 −78.0 
               
               
                 Minimum 
                 258.0 
                 149.0 
                 157.0 
                 176.0 
                 166.0 
                 185.0 
                 190.0 
                 182.0 
                 −138.0 
               
               
                 Maximum 
                 413.0 
                 345.0 
                 335.0 
                 359.0 
                 328.0 
                 336.0 
                 366.0 
                 350.0 
                 30.0 
               
               
                 Standard 
                 10.9 
                 13.2 
                 12.9 
                 12.0 
                 12.5 
                 10.9 
                 10.5 
                 10.7 
                 9.8 
               
               
                 error 
               
               
                 IC of 95% 
                 [300.9; 
                 [221.2; 
                 [210.1; 
                 [215.4; 
                 [209.5; 
                 [224; 
                 [236.2; 
                 [236.5; 
                 [−94.8; 
               
               
                   
                 344.6] 
                 273.9] 
                 261.9] 
                 263.4] 
                 259.6] 
                 267.7] 
                 278.2] 
                 279.2] 
                 −55.5] 
               
             
          
           
               
                 Δ (%) with respect to T0 
                 −23.3 
               
               
                   
               
             
          
           
               
                   
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                 Subject 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
               
               
                 002 
                 −115 
                 −121 
                 −101 
                 −77 
                 −77 
                 −98 
               
               
                 004 
                 27 
                 −9 
                 16 
                 3 
                 −13 
                 18 
               
               
                 005 
                 −100 
                 −97 
                 −100 
                 −84 
                 −88 
                 −78 
               
               
                 006 
                 −114 
                 −87 
                 −103 
                 −84 
                 −106 
                 −101 
               
               
                 007 
                 −144 
                 −126 
                 −77 
                 −138 
                 −95 
                 −69 
               
               
                 008 
                 −100 
                 −102 
                 −103 
                 −119 
                 −105 
                 −127 
               
               
                 009 
                 −66 
                 −71 
                 −68 
                 −72 
                 −30 
                 −76 
               
               
                 010 
                 −76 
                 −37 
                 −41 
                 −39 
                 −35 
                 −33 
               
               
                 012 
                 −57 
                 −58 
                 −60 
                 −43 
                 33 
                 −4 
               
               
                 013 
                 −64 
                 −58 
                 −63 
                 −78 
                 −47 
                 −33 
               
               
                 014 
                 −107 
                 −88 
                 −86 
                 −79 
                 −69 
                 −69 
               
               
                 015 
                 −90 
                 −113 
                 −110 
                 −100 
                 −90 
                 −60 
               
               
                 016 
                 −101 
                 −105 
                 −110 
                 −86 
                 −44 
                 −28 
               
               
                 017 
                 −172 
                 −108 
                 −157 
                 −115 
                 −103 
                 −114 
               
               
                 018 
                 −102 
                 −54 
                 −88 
                 −77 
                 −47 
                 −66 
               
               
                 019 
                 −68 
                 −113 
                 −125 
                 −64 
                 −93 
                 −72 
               
               
                 020 
                 −67 
                 −82 
                 −142 
                 −61 
                 −54 
                 −77 
               
               
                 021 
                 −93 
                 −91 
                 −111 
                 −90 
                 −97 
                 −62 
               
               
                 022 
                 −39 
                 −64 
                 −46 
                 −58 
                 −86 
                 −84 
               
               
                 Average 
                 −86.7 
                 −83.4 
                 −88.2 
                 −76.9 
                 −65.6 
                 −64.9 
               
               
                 Medium 
                 −93.0 
                 −88.0 
                 −100.0 
                 −78.0 
                 −77.0 
                 −69.0 
               
               
                 Minimum 
                 −172.0 
                 −126.0 
                 −157.0 
                 −138.0 
                 −106.0 
                 −127.0 
               
               
                 Maximum 
                 27.0 
                 −9.0 
                 16.0 
                 3.0 
                 33.0 
                 18.0 
               
               
                 Standard 
                 9.6 
                 7.1 
                 9.1 
                 7.2 
                 8.5 
                 8.3 
               
               
                 error 
               
               
                 IC of 95% 
                 [−105.9; 
                 [−97.5; 
                 [−106.3; 
                 [−91.3; −62.5] 
                 [−82.6; 
                 [−81.5; −48.3] 
               
               
                   
                 −67.6] 
                 −69.2] 
                 −70.1] 
                   
                 −48.5] 
               
               
                 Δ (%) with respect 
                 −26.9 
                 −25.8 
                 −27.3 
                 −23.8 
                 −20.3 
                 −20.1 
               
               
                 to T0 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
               
               
               
               
               
               
             
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 35 
               
               
                   
               
               
                 Measurements and descriptive statistics of the control 
               
               
                   
               
             
             
               
                   
               
             
          
           
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Δ (T30- 
               
               
                   
                   
                 T30- 
                   
                   
                   
                   
                   
                   
                 min − 
               
               
                 Subject 
                 T0 
                 min 
                 T1 h 
                 T2 h 
                 T3 h 
                 T4 h 
                 T5 h 
                 T6 h 
                 T0) 
               
               
                   
               
               
                 002 
                 291 
                 194 
                 214 
                 201 
                 216 
                 245 
                 245 
                 241 
                 −97 
               
               
                 004 
                 322 
                 327 
                 326 
                 283 
                 301 
                 318 
                 314 
                 297 
                 5 
               
               
                 005 
                 256 
                 193 
                 178 
                 189 
                 189 
                 189 
                 210 
                 196 
                 −63 
               
               
                 006 
                 323 
                 282 
                 242 
                 250 
                 258 
                 248 
                 250 
                 242 
                 −41 
               
               
                 007 
                 213 
                 175 
                 181 
                 176 
                 217 
                 198 
                 226 
                 221 
                 −38 
               
               
                 008 
                 338 
                 304 
                 297 
                 287 
                 288 
                 267 
                 270 
                 280 
                 −34 
               
               
                 009 
                 334 
                 259 
                 231 
                 213 
                 202 
                 176 
                 228 
                 200 
                 −75 
               
               
                 010 
                 172 
                 202 
                 166 
                 206 
                 180 
                 200 
                 163 
                 184 
                 30 
               
               
                 012 
                 285 
                 234 
                 204 
                 232 
                 209 
                 230 
                 271 
                 262 
                 −51 
               
               
                 013 
                 364 
                 279 
                 299 
                 329 
                 365 
                 329 
                 349 
                 352 
                 −85 
               
               
                 014 
                 258 
                 195 
                 205 
                 195 
                 216 
                 185 
                 191 
                 219 
                 −63 
               
               
                 015 
                 236 
                 160 
                 151 
                 147 
                 156 
                 212 
                 189 
                 194 
                 −76 
               
               
                 016 
                 351 
                 273 
                 292 
                 344 
                 278 
                 257 
                 276 
                 290 
                 −78 
               
               
                 017 
                 397 
                 238 
                 218 
                 251 
                 209 
                 257 
                 251 
                 260 
                 −159 
               
               
                 018 
                 368 
                 327 
                 267 
                 305 
                 289 
                 272 
                 322 
                 327 
                 −41 
               
               
                 019 
                 374 
                 298 
                 290 
                 264 
                 235 
                 329 
                 320 
                 311 
                 −76 
               
               
                 020 
                 319 
                 244 
                 274 
                 237 
                 215 
                 259 
                 254 
                 258 
                 −75 
               
               
                 021 
                 313 
                 235 
                 235 
                 228 
                 233 
                 248 
                 246 
                 238 
                 −78 
               
               
                 022 
                 382 
                 333 
                 322 
                 336 
                 328 
                 312 
                 291 
                 297 
                 −49 
               
               
                 Average 
                 310.3 
                 250.1 
                 241.7 
                 245.9 
                 241.3 
                 249.0 
                 256.1 
                 256.3 
                 −60.2 
               
               
                 Medium 
                 322.0 
                 244.0 
                 235.0 
                 237.0 
                 217.0 
                 248.0 
                 251.0 
                 258.0 
                 −63.0 
               
               
                 Minimum 
                 172.0 
                 160.0 
                 151.0 
                 147.0 
                 156.0 
                 176.0 
                 163.0 
                 184.0 
                 −159.0 
               
               
                 Maximum 
                 397.0 
                 333.0 
                 326.0 
                 344.0 
                 365.0 
                 329.0 
                 349.0 
                 352.0 
                 30.0 
               
               
                 Standard 
                 14.0 
                 12.4 
                 12.4 
                 13.0 
                 12.4 
                 11.1 
                 11.3 
                 11.0 
                 9.0 
               
               
                 error 
               
               
                 IC of 
                 [282.3; 
                 [225.3; 
                 [216.9; 
                 [220; 
                 [216.5; 
                 [226.7; 
                 [233.4; 
                 [234.2; 
                 [−78.3; 
               
               
                 95% 
                 338.3] 
                 274.9] 
                 266.4] 
                 271.8] 
                 266.1] 
                 271.3] 
                 278.8] 
                 278.3] 
                 −42.2] 
               
             
          
           
               
                 Δ (%) em relação ao T0 
                 −19.4 
               
               
                   
               
             
          
           
               
                   
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
                 Δ 
               
               
                   
                 (T1 h − 
                 (T2 h − 
                 (T3 h − 
                 (T4 h − 
                 (T5 h − 
                 (T6 h − 
               
               
                 Subject 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
                 T0) 
               
               
                   
               
               
                 002 
                 −77 
                 −90 
                 −75 
                 −46 
                 −46 
                 −50 
               
               
                 004 
                 4 
                 −39 
                 −21 
                 −4 
                 −8 
                 −25 
               
               
                 005 
                 −78 
                 −67 
                 −67 
                 −67 
                 −46 
                 −60 
               
               
                 006 
                 −81 
                 −73 
                 −65 
                 −75 
                 −73 
                 −81 
               
               
                 007 
                 −32 
                 −37 
                 4 
                 −15 
                 13 
                 8 
               
               
                 008 
                 −41 
                 −51 
                 −50 
                 −71 
                 −68 
                 −58 
               
               
                 009 
                 −103 
                 −121 
                 −132 
                 −158 
                 −106 
                 −134 
               
               
                 010 
                 −6 
                 34 
                 8 
                 28 
                 −9 
                 12 
               
               
                 012 
                 −81 
                 −53 
                 −76 
                 −55 
                 −14 
                 −23 
               
               
                 013 
                 −65 
                 −35 
                 1 
                 −35 
                 −15 
                 −12 
               
               
                 014 
                 −53 
                 −63 
                 −42 
                 −73 
                 −67 
                 −39 
               
               
                 015 
                 −85 
                 −89 
                 −80 
                 −24 
                 −47 
                 −42 
               
               
                 016 
                 −59 
                 −7 
                 −73 
                 −94 
                 −75 
                 −61 
               
               
                 017 
                 −179 
                 −146 
                 −188 
                 −140 
                 −146 
                 −137 
               
               
                 018 
                 −101 
                 −63 
                 −79 
                 −96 
                 −46 
                 −41 
               
               
                 019 
                 −84 
                 −110 
                 −139 
                 −45 
                 −54 
                 −63 
               
               
                 020 
                 −45 
                 −82 
                 −104 
                 −60 
                 −65 
                 −61 
               
               
                 021 
                 −78 
                 −85 
                 −80 
                 −65 
                 −67 
                 −75 
               
               
                 022 
                 −60 
                 −46 
                 −54 
                 −70 
                 −91 
                 −85 
               
               
                 Average 
                 −68.6 
                 −64.4 
                 −69.1 
                 −61.3 
                 −54.2 
                 −54.1 
               
               
                 Medium 
                 −77.0 
                 −63.0 
                 −73.0 
                 −65.0 
                 −54.0 
                 −58.0 
               
               
                 Minimum 
                 −179.0 
                 −146.0 
                 −188.0 
                 −158.0 
                 −146.0 
                 −137.0 
               
               
                 Maximum 
                 4.0 
                 34.0 
                 8.0 
                 28.0 
                 13.0 
                 12.0 
               
               
                 Standard 
                 9.0 
                 9.4 
                 11.4 
                 10.0 
                 8.7 
                 9.0 
               
               
                 error 
               
               
                 IC of 
                 [−86.6; 
                 [−83.1; 
                 [−91.9; −46.2] 
                 [−81.4; −41.3] 
                 [−71.6; 
                 [−72.1; −36] 
               
               
                 95% 
                 −50.6] 
                 −45.7] 
                   
                   
                 −36.8] 
               
               
                 Δ (%) em relação 
                 −22.1 
                 −20.7 
                 −22.3 
                 −19.8 
                 −17.5 
                 −17.4 
               
               
                 ao T0 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
               
               
             
               
               
               
               
               
               
               
             
               
               
               
               
               
               
               
             
           
               
                 TABLE 36 
               
             
             
               
                   
               
               
                 Average and standard error for each treatment per 
               
               
                 time and for the difference between treatments 
               
             
          
           
               
                   
                 Product 
                 Control 
                 Product − Control 
               
             
          
           
               
                 Time 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
                 Average 
                 E.P. 
               
               
                   
               
             
          
           
               
                 T0 
                 322.7 
                 10.9 
                 310.3 
                 14.0 
                 12.4 
                 11.7 
               
               
                 T30 min 
                 247.6 
                 13.2 
                 250.1 
                 12.4 
                 −2.5 
                 6.1 
               
               
                 T1 h 
                 236.0 
                 12.9 
                 241.7 
                 12.4 
                 −5.7 
                 8.7 
               
               
                 T2 h 
                 239.4 
                 12.0 
                 245.9 
                 13.0 
                 −6.6 
                 10.1 
               
               
                 T3 h 
                 234.6 
                 12.5 
                 241.3 
                 12.4 
                 −6.7 
                 8.7 
               
               
                 T4 h 
                 245.8 
                 10.9 
                 249.0 
                 11.1 
                 −3.2 
                 6.0 
               
               
                 T5 h 
                 257.2 
                 10.5 
                 256.1 
                 11.3 
                 1.1 
                 6.7 
               
               
                 T6 h 
                 257.8 
                 10.7 
                 256.3 
                 11.0 
                 1.6 
                 6.2 
               
               
                   
               
             
          
         
       
     
         [0000]    
       
         
               
             
               
               
             
               
               
               
               
             
               
               
               
               
             
           
               
                 TABLE 37 
               
             
             
               
                   
               
               
                 Porcentage of variation in the average with respect to the T0 
               
               
                 and percentage of volunteers with positive and negative effect 
               
             
          
           
               
                   
                 Produto − Controle 
               
             
          
           
               
                   
                 % of 
                   
                   
               
               
                   
                 variation with 
                 % of subjects with 
                 % of subjects with 
               
               
                 Time 
                 respect to T0 
                 positive effect 
                 negative effect 
               
               
                   
               
             
          
           
               
                 T30 min 
                 −3.9 
                 63.2 
                 36.8 
               
               
                 T1 h 
                 −4.8 
                 63.2 
                 36.8 
               
               
                 T2 h 
                 −5.1 
                 73.7 
                 21.1 
               
               
                 T3 h 
                 −5.1 
                 68.4 
                 21.1 
               
               
                 T4 h 
                 −4.1 
                 63.2 
                 36.8 
               
               
                 T5 h 
                 −2.9 
                 68.4 
                 31.6 
               
               
                 T6 h 
                 −2.7 
                 63.2 
                 36.8 
               
               
                   
               
             
          
         
       
     
         [0238]    No significant difference was found between the treatments in the times T30min, T1h, T4h, T5h and T6h (P-values=0.138; 0.054; 0.147; 0.250; 0.207, respectively). The product was inferior to the control in the times T2h and T3h (p-values =0.048; 00.41, respectively). 
       Wherein: 
       [0239]    Cm2: square centimeters;
 
G: grams;
 
H: hours;
 
No.: number;
 
° C.; degrees Celsius;
 
Tx: Time after x hours from application of the product.
 
       6.7—Conclusion 
       [0000]    
       
         
           
             After a statistical analysis of the results, one can conclude that the composition of the invention promoted the reduction of the erythema in the times T2h and T3h as compared with the control.