Face Aging/Photo Aging of Moderate Grade
Conditions
Brief summary
Efficacy and Tolerance Evaluation of arevitalizing face treatment consisting of a day and a night cream
Detailed description
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.
Interventions
OTHERNutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)
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
Sponsors
Derming SRL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of vascular and pigmentary homogeneity clinical score | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | Homogeneity grade was determined according to specific reference clinical and photographic scales and to the following clinical score: 0 = very homogeneous 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = marked not homogeneous |
| Change of skin recovery after pinching clinical score | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important 1. = important 2. = moderate 3. = weak 4. = very weak |
| Change of skin dryness clinical score | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | Clinical evaluation of skin dryness was performed according to the following score: 0 = very hydrated skin 1. = hydrated skin 2. = normal skin 3. = kindly dry skin 4. = dry skin 5. = very dry skin |
| Change of skin resistance to pinching clinical score | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important 1. = important 2. = moderate 3. = weak 4. = very weak |
| Change of wrinkles grade, around the eyes (Crow's feet) | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 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 |
| Change of wrinkles grade of nasolabial folds | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 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 |
| Change of skin surface microrelief's regularity | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 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. |
| Change of skin resistance to traction clinical score | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | The evaluation was performed at level of cheek (malar region) according to the following score: 0 = very important 1. = important 2. = moderate 3. = weak 4. = very weak |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Photographic documentation (3D pictures) | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | Three-dimensional pictures of the face taken by VECTRA H1 handheld imaging system. |
| Change of roughness profilometric parameters | Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3) | 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. |
Countries
Italy
Outcome results
None listed