Face Aging/Photo Aging of Moderate Grade Clinical Trial
Official title:
Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment
| Verified date | September 2017 |
| Source | Derming SRL |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | June 30, 2017 |
| Est. primary completion date | June 30, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 35 Years to 60 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Italy | DERMING | Monza | Monza-brianza |
| Lead Sponsor | Collaborator |
|---|---|
| Derming SRL |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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) | |
| Primary | 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 | 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) | |
| Secondary | 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) |