Efficacy and Tolerance Evaluation of a Topical Revitalizing Face Day Cream

Study Overview
=================
Brief Summary
-----------------
Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the revitalizing activity of a face cream applied twice a day, morning and evening, for an uninterrupted period of 8 weeks, by healthy female volunteers aged 45-55 years with face ritidosis and women aged 55-65 years not habitual user of antiage-creams. The study foresaw the comparison within subjects of the study product versus placebo (half face method). It was also aim of this study to evaluate products efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.

Official Title
-----------------
Efficacy and Tolerance Evaluation of a Topical Revitalizing Face Day Cream: Comparison Within Subjects Versus Placebo

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

Intervention / Treatment
-----------------
* Other: plantaricin a (active product)
* Other: placebo product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female healthy subjects age 45-55 years women aged 55-65 years who are not habitual user of antiage-creams presence of moderate face ritidosis agreeing to present at each study visit without make-up accepting to not change their habits regarding food, physical activity, face cleansing and make- up use accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study accepting to sign the Informed consent form Exclusion Criteria: pregnancy lactation change in the normal habits regarding foods, physical activity, face cleansing and make-up use during the month preceding the test sensitivity to the test products or theirs ingredients subjects whose insufficient adhesion to the study protocol is foreseeable participation in a similar study actually or during the previous 3 months change in the normal life habits during the month preceding the inclusion dermatological disease (dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations; recurrent facial/labial herpes) clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis etc.) diabetes endocrine disease hepatic disorder renal disorder cardiac disorder pulmonary disease cancer neurological or psychological disease inflammatory/immunosuppressive disease drug allergy drugs/cutaneous medical or surgical procedures at level of the tested area during the previous 3 months anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year); assumption of drugs able to influence the test results in the investigator opinion

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: plantaricin a (active product)<br>Volunteers applied the active product for an uninterrupted period of 8 weeks (on the right or on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage. | Other: plantaricin a (active product)<br>* Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage<br>|
| Other: placebo product<br>Volunteers applied the placebo product for an uninterrupted period of 8 weeks (on the right or on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage | Other: placebo product<br>* Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profilometry: change from baseline (T4 and T8 vs. T0) | A picture of crow's feet area was taken thanks to Primos compact portable device (GFMesstechnik); a software able to elaborate 3D representations of skin wrinkles as well as to measure skin principal profilometric parameters in vivo or on skin replicas, according to the law DIN EN ISO 4228; moreover the software compares directly the different images obtained at the times foresee by the protocol (T0, T4 and T8).The portable probe assures a constant distance from the skin as well as a fixed illumination angle of incidence; in this way is possible to acquire standardized and reproducible images. | T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin electrical capacitance: change from baseline (T4 and T8 vs. T0) | Hydration is measured by the instrument Corneometer CM825 (Courage - Khazaka, Köln, Germany): a square sensor (49mm2) frontally covered by a special glass, mounted on a spring cursor able to measure electrical capacity. Leaning the sensor on the skin surface, with a constant pressure thanks to the spring cursor it is possible to perform measures. The sensor acts as a capacitor. When a voltage is applied to this capacitor, the quantity of electric charge stored will be dependent on the dielectric properties of the material in contact with the probe. Water has an unusually high dielectric constant and so its presence in the skin is readily detectable by this method. So the measure of the skin capacitance properties is an indirect expression of its hydration level. To reduce the variability of measurement methods, for each evaluated side, three measures on the same skin area were executed: the adjusted mean will be considered as the real measure value. | T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) | 
| Skin plastoelasticity: change from baseline (T4 and T8 vs. T0) | Skin plastoelasticity is measured with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK). This instrument is based on the principle of the torsion given to the skin surface by a probe made of two circles that adhere to the skin through shaped adhesive tapes. The internal circle rotation, while the external circle is still, exerts a constant torsion of the skin (torsion time = 1 second with a torque = 9mN*m). The instrument measures the torsion angle (θ) during the mechanical stimulus (torque on) and after it has ceased (torque off).For each of the considered curves the cutaneous rotational ratio relative to defined measured times can be measured, obtaining the parameters listed below: Ue: immediate extensibility (torque on at 0.02 sec.) Uf: maximum extensibility (torque on at 0.9 sec.) Uv: viscoelasticity Ur: immediate elastic recovery (torque off at 0.02 sec.). | T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) | 
| Spectophotometry: change from baseline (T4 and T8 vs. T0) | Skin colour was measured by a visible-UV-IR (λ from 300 to 900 nm) spectrophotometer which use a tungsten halogen lamp and a deuterium lamp in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. Lamps were switched on 30 minutes before instrument use in order to join a stable emission. Measurement angle was 90° (position of the probe on the skin) and measured area was 2 mm2; used wavelength range was 380-780 nm corresponds to the visible light spectrum. | T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) | 
| Optical colorimetry: change from baseline (T4 and T8 vs. T0) | Measurement of skin brightness was performed by a tri-stimulus colorimeter (Chroma Meter CR-200®) equipped with three special filters to obtain R,G,B values in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. CIE L*a*b* system (CIELAB) is the most complete colour-space specified by the CIE (1976). It describes all the colours visible to the human eye; the three coordinates of L*a*b* represent the lightness of the colour (L* = 0 yields black and L* = 100 indicates diffuse white; specular white may be higher), its position between red/magenta and green (a*, negative values indicate green while positive values indicate magenta) and its position between yellow and blue (b*, negative values indicate blue and positive values indicate yellow). | T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) | 
| Tape stripping: | Tape stripping was performed at each study time on the forehead on 10 selected subjects. The skin was not cleaned before tape stripping and tested area were marked with a black washable pencil. D-squame® discs (Monaderm, Monaco) with a diameter of 22mm were placed on the site of application (area without hair), applied with a constant pressure for 15 sec and then peeled off. The first two strips were discharged. Third and fourth strip were collected and stored at -20°C until following analysis listed below: protein extraction and quantification microscopic analysis study of the expression of biological markers associated with skin ageing study of ageing/oxidative stress | T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment) | 
| Clinical evaluations: change from baseline (T4 and T8 vs. T0) | The following clinical evaluations were performed: wrinkles grade (nasolabial folds and crow's feet): 0 = no wrinkles; 1= very weak wrinkles; 2 = weak wrinkles; 3= quite evident wrinkles; 4 = evident wrinkles; 5 = very evident wrinkles; 6 = marked wrinkles; 7 = very marked wrinkles submental ptosis, scored from 0 (absence of ptosis - very regular oval face) to 5 (very marked ptosis - very irregular oval face) according to a clinical photographic scale. surface microrelief: 1 = very regular; 2 = regular; 3 = irregular; 4 = very irregular skin dullness (overall face): 1= luminous skin;2 = normal skin; 3= opaque skin; 4= very opaque skin skin resistance to pinching, to traction and recovery after pinching (malar region): 0 = very important;1 = important; 2 = moderate; 3 = weak; 4 = very weak skin dryness (malar region): 0 = very hydrated skin; 1= hydrated skin; 2 = normal skin; 3= kindly dry skin; 4= dry skin ; 5= very dry skin | T0 (basal conditions), T4 and T8 (after 4 and 8 week-treatment) | 
| Photographic documentation: | In basal condition (T0), at T4 and at T8 the investigator took lateral pictures of each volunteer. In order to assure comparable images, the pictures were taken with standardised methods, concerning especially: magnification factor intensity of illumination source (photographic lamps) angle of incidence and inclination of illumination Thanks to the application remote trigger (Canon EOS utility software) it was possible to overlay the first photographic image (T0) with the ones taken in the following times (T4 and T8); so it was possible to have totally comparable images. | T0 (basal condition), T4 and T8 (after 4 and 8 week-treatment) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wrinkles, skin aging, anti-aging cream