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Effect of an antioxidant cosmetic skin cream on healthy participants

Placebo/benchmark-controlled, randomized, double blind clinical study aimed to evaluate in situ the antioxidant efficacy of a cosmetic product

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN49855247
Enrollment
20
Registered
2016-06-28
Start date
2012-03-13
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antioxidant efficacy of a cosmetic product Skin and Connective Tissue Diseases

Interventions

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%

Sponsors

Pierre Fabre Dermo Cosmétique
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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)

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026