Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations

Study Overview
=================
Brief Summary
-----------------
Aim of the study was to evaluate the soothing and re-epithelizing activity of a single application of topical products on experimentally induced erythema by skin stripping on the forearm (volar surface) of 20 healthy volunteers. In particular the activity of the following three cosmetic products and the relative combinations (cream and serum) were assessed: rejuvenating cream, rejuvenating serum, antioxidant serum

Official Title
-----------------
Short Term Evaluation of the Soothing and Re-epithelizing Activity of Three Topical Products and Relative Combinations

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: plantaricin a - rejuvenating cream
* Other: plantaricin a - antioxidant serum
* Other: plantaricin a - rejuvenating serum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult volunteers of both sexes, aged more than 18 years old Volunteers in a good general state of health in the Investigator opinion Volunteers not taking drugs or undergoing surgical procedure Volunteers who are giving a written informed consent. Exclusion Criteria: Pregnancy (only for female subjects) lactation (only for female subjects) change in the normal habits in the last month participation in a similar study during the previous month known allergy to one or several ingredients of the products on trial insufficient adhesion to the study protocol dermatological disease clinical and significant skin condition on the test area (e.g. lesions, scars, malformations) diabetes endocrine disease hepatic, renal or cardiac disorder cancer topical drugs or surgical procedure on the test areas during the previous 3 months systemic corticosteroids aspirin or non-steroid anti-inflammatory drugs (FANS) diuretic drugs antibiotics and chemotherapics pshycotropic drugs retinoids psoralens cardiologic and vascular drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: plantaricin a - rejuvenating cream<br>single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other: plantaricin a - rejuvenating cream<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>|
| Active Comparator: plantaricin a - rejuvenating serum<br>single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other: plantaricin a - rejuvenating serum<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>|
| Active Comparator: plantaricin a - antioxidant serum<br>single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other: plantaricin a - antioxidant serum<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>|
| Active Comparator: plantaricin a (rejuvenating cream +rejuvenating serum)<br>single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other: plantaricin a - rejuvenating cream<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>Other: plantaricin a - rejuvenating serum<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>|
| Active Comparator: plantaricin a (rejuvenating cream + antioxidant serum)<br>single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes | Other: plantaricin a - rejuvenating cream<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>Other: plantaricin a - antioxidant serum<br>* single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of skin erythema: change from baseline, 1 hour after products application (T1h vs. T0) | Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth) | After 1 (T1h) hour from products application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of skin erythema: change from baseline, 6 hours from products application (T6h vs. T0) | Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth) | After 6 (T6h) hours from products application | 
| Clinical evaluation of skin erythema: change from baseline, after 24 hours from products application (T24h vs. T0) | Skin erythema was scored and recorded according to the following grades: 0=no erythema; 0.5=very slight erythema (barely perceptible);1=well-defined erythema;1.5=moderate to severe erythema; 2=severe erythema (beet redness) to slight eschar formation (injuries in depth) | After 24 (T24h) hours from products application | 
| Optical densitometry: change from baseline, after 1hour from products application (T1h vs. T0) | The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan | After 1 (T1h) hour from products application | 
| Optical densitometry: change from baseline, 6 hours from products application (T6h vs. T0) | The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan | After 6 (T6h) hours from products application | 
| Optical densitometry: change from baseline, 24 hours from products application (T24h vs.T0) | The instrumental measurement of erythema was performed by the use of an optical densitometer allowing to quantify, on a logarithmic scale, total reflected optical density (visual=V) and the values of primary subtractive colours of reflected light: cyan(=C), magenta(=M) and yellow(=Y). Calculation of erythema index was done as follows: E.I.=logRmagenta-logRcyan | After 24 (T24h) hours from products application | 
| Surface microrelief evaluation: change from baseline, after 1 hour from products application (T1h vs.T0) | Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope. | After 1 (Th1) hour from products application | 
| Surface microrelief evaluation: change from baseline, 6 hours from products application (T6h vs. T0) | Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope. | After 6 (T6h) hours from products application | 
| Surface microrelief evaluation: change from baseline, after 24 hours from products application (T24h) hours from products application vs.T0) | Morfometrical analysis of cutaneous surface allows the evaluation of the regularity of the microrelief (superficial cutaneous network). It was therefore possible to determinate the alteration of the microrelief caused by stripping.The evaluation of the regularity grade of cutaneous microrelief was possible using Fast Fourier Transform (FFT) on skin replicas obtained using silicone rubber. Skin replicas images were then acquired by a stereo microscope. | After 24 hours (T24h) from products application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin eythema, rejuvenating cream, rejuvenating serum, antioxidant serum