Efficacy and Tolerance Evaluation of a Revitalizing Face Treatment

Study Overview
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Brief Summary
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Efficacy and Tolerance Evaluation of arevitalizing face treatment consisting of a day and a night cream

Detailed Description
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Aim of the study was to evaluate clinically and by non-invasive instrumental evaluations the activity of a revitalizing face treatment consisting of a day and a night cream, applied for an uninterrupted period of 3 months, by female volunteers, aged 35-60 years, with aging/photo aging of moderate grade.

Official Title
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Efficacy and Tolerance Evaluation of a Revitalizing Face Treatment

Conditions
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Face Aging/Photo Aging of Moderate Grade

Intervention / Treatment
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* Other: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: female sex, age 35-60 years, Caucasian subjects, presence of moderate face ritidosis, agreeing to present at each study visit without make-up, accepting to follow the instructions received by the investigator, accepting to not change their habits regarding food, physical activity, face cleansing and make- up use, agreeing not to apply or take any product or use face massages or other means known to improve skin wrinkle and skin qualities during the entire duration of the study, accepting not to expose their face to strong UV irradiation (UV session, or sun bathes), during the entire duration of the study, no participation in a similar study currently or during the previous 3 months accepting to sign the Informed consent form. Exclusion Criteria: Pregnancy, lactation, sensitivity to the test products or their ingredients (to be assessed by the investigator during the baseline visit), subjects whose insufficient adhesion to the study protocol is foreseeable. 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.). endocrine disease, hepatic disorder, renal disorder, cardiac disorder, pulmonary disease, cancer, neurological or psychological disease, inflammatory/immunosuppressive disease, drug allergy. anti-inflammatory drugs, anti-histaminic, topic (application on the face) and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of hormonal treatment starting more than 1 year ago), using of drugs or dietary supplements able to influence the test results in the investigator opinion.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutriage SPF 30 day cream and Nutriage night cream<br>Application of the study products (day cream at the morning and night cream at the evening), for an uninterrupted period of 3 months. | Other: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)<br>* A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of wrinkles grade, around the eyes (Crow's feet) | Variation of wrinkles grade from baseline of the Glogau's reference photographic scale (visual score from 1-4) where: Type 1: early wrinkles Type 2: wrinkle in motion Type 3: wrinkles at rest Type 4: Only wrinkles | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of wrinkles grade of nasolabial folds | Variation of wrinkles grade from baseline of the Lemperle's reference photographic scale (visual score from 1-6) where: Grade 1: no wrinkles Grade 2: just perceptible wrinkles Grade 3: shallow wrinkles Grade 4: moderately deep wrinkles Grade 5: deep wrinkles, well-defined folds Grade 6: very deep wrinkles, redundant fold | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of skin surface microrelief's regularity | Variation of skin surface microrelief's regularity grade from baseline of cheek surface microrelief photographic scale where: Grade 1:very regular Grade 2: regular Grade 3: irregular Grade 4: very irregular. | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of skin resistance to pinching clinical score | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important = important = moderate = weak = very weak | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of skin resistance to traction clinical score | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important = important = moderate = weak = very weak | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of skin recovery after pinching clinical score | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important = important = moderate = weak = very weak | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of skin dryness clinical score | Clinical evaluation of skin dryness was performed according to the following score: 0 = very hydrated skin = hydrated skin = normal skin = kindly dry skin = dry skin = very dry skin | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Change of vascular and pigmentary homogeneity clinical score | Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous = homogeneous = quite not homogeneous = not homogeneous = very not homogeneous = marked not homogeneous | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of roughness profilometric parameters | Crow's feet profilometric parameters measured by Primos compact portable device (GFMesstechnik). Ra is average roughness of the analysed profile, Rt is wrinkles total high, Rv is wrinkles maximum depth. | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 
| Photographic documentation (3D pictures) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) |