Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment

NCT03276897 | Completed

• 1 other identifier: E0517
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and Tolerance Evaluation of a"revitalizing" face treatment consisting of a day and a night cream

Conditions

Face Aging/Photo Aging of Moderate Grade

Outcome Measures

Primary Outcomes (8)

• 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 1. = important 2. = moderate 3. = weak 4. = 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 1. = important 2. = moderate 3. = weak 4. = 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 1. = important 2. = moderate 3. = weak 4. = 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 1. = hydrated skin 2. = normal skin 3. = kindly dry skin 4. = dry skin 5. = 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 1. = homogeneous 2. = quite not homogeneous 3. = not homogeneous 4. = very not homogeneous 5. = marked not homogeneous

  Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

Secondary Outcomes (2)

• Change of roughness profilometric parameters

  Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

• Photographic documentation (3D pictures)

  Baseline visit (T0), 1 month (T1), 2 months (T2), 3 months (T3)

Study Arms (1)

Nutriage SPF 30 day cream and Nutriage night cream

EXPERIMENTAL

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)

Interventions

Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy) OTHER

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

Nutriage SPF 30 day cream and Nutriage night cream

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Derming SRL: lead

Study Sites (1)

DERMING

Monza, Monza-brianza, 20900, Italy

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 8, 2017
• Study Start: March 21, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

IT (1)