Efficacy and Tolerance Evaluation of a "Revitalizing" Face Treatment

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

Study Overview

• Status: Completed
• Conditions: Face Aging/Photo Aging of Moderate Grade
• Intervention / Treatment: Other: Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Monza-brianza
    • Monza, Monza-brianza, Italy, 20900
      • DERMING

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Nutriage SPF 30 day cream and Nutriage night cream; 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); 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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Derming SRL

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 21, 2017
• Primary Completion (ACTUAL): June 30, 2017
• Study Completion (ACTUAL): June 30, 2017

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (ACTUAL): September 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 6, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: E0517

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No