Effect of an antioxidant cosmetic skin cream on healthy participants

• Register: ISRCTN
• Last refreshed on: 25 July 2023
• Main ID: ISRCTN49855247
• Date of registration: 28/06/2016
• Prospective Registration: No
• Primary sponsor: Pierre Fabre Dermo Cosmétique
• Public title: Effect of an antioxidant cosmetic skin cream on healthy participants
• Scientific title: Placebo/benchmark-controlled, randomized, double blind clinical study aimed to evaluate in situ the antioxidant efficacy of a cosmetic product
• Date of first enrolment: 13/03/2012
• Target sample size: 20
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN49855247
• Study type: Interventional
• Study design: Single-centre double-blind randomised placebo- and active-controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Italy

Contacts

• Name: Virginie Ribet

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 years or over
2. Healthy
3. Caucasian skin type: II, III and IV according to Fitzpatrick classification
4. Showing clinical signs of skin ageing due to physiological ageing (chrono-ageing) and chronological ageing
5. Have not been recently involved in any other similar study
6. Agree to not use during all the study period topic products/dietary supplements with similar effect to that one of the product to be tested (antioxidant)
7. Have not had sun exposure on the back area for at least two months prior to the study
8. Free from of sunburn, suntan, scars, or active dermal lesions on the areas of the back selected for the test purposes
9. Test area must be uniform in colour, without nevi, blemishes or solar lentigo and without hairs
10. Agree not to change the daily routine
Exclusion criteria: 1. Pregnant or nursing women
2. History of allergies or sensitivity to cosmetic products, toiletries, sunscreens and/or topical drugs
3. Dermatological problems on the test area
4. Under pharmacological treatment (both locally or systemically)
5. Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the body not in direct contact with the allergen)
6. Use of self-tanning products in the previous month after the date of the study
7. Accustomed to using tanning beds
8. Taking medication with photosensitizing potential, drugs and/or dietary supplements able to induce skin colouring, corticoids, currently or during the month before the study
9. Positive anamnesis for atopy (allergic hypersensitivity affecting parts of the body not in direct contact with the allergen)

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Antioxidant efficacy of a cosmetic product
Skin and Connective Tissue Diseases

Intervention(s)

On each participant, four skin sites on the legs are randomly allocated to receive application of four different treatments daily for 30 days.

Site 1: Test cream, which contains basal cream and 0.1% pre-tocopheryl (vitamin E precursor), 0.1% retinaldehyde (Vitamin A) and 0.1% glycyl glycineoleamide (GGO: a small amphiphilic molecule that protect the connective tissue of the skin from glycation and elastosis)
Site 2: Basal cream with 2% vitamin E (positive control)
Site 3: Placebo, which contains basal cream without any active ingredient
Site 4: No cream/treatment applied

Participants attend clinic visits at baseline and after 15 and 30 days of treatment. At each visit, participants are exposed to UVA radiation and skin samples are collected on all sites 4 and 24 hours after UVA exposure.

Primary Outcome(s)

Antioxidant activity is measured using Fluorescence Recovery After Photobleaching (FRA) at baseline, 15 and 30 days.

Secondary Outcome(s)

Lipid peroxidation is measured by completing a Lipid Peroxidation (MDA) Assay in each area at baseline, 15 and 30 days of cream application.

Secondary ID(s)

RV4400A2011625

Source(s) of Monetary Support

Pierre Fabre Dermo Cosmétique

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; Not provided at time of registration.

Results

• Results available: Yes
• Date Completed: 12/07/2012