Plain English Summary
Background and study aims
As we age our skin ages, leading to noticeable changes such as wrinkles, dark spots and dryness. It is though that one of the major causes of skin ageing is sun exposure. When the sun shines on our skin, it produces a dark pigment called melanin which makes us appear tanned while protecting against potentially harmful ultraviolet (UV) rays. Many studies have shown that long-term exposure to UV light causes our skin to age more quickly. It is thought that this is because of a process called oxidative stress, in which free radicals (unstable molecules) attack the DNA of our skin cells, causing them to die. Free radicals are naturally produced as our cells process oxygen however this process is worsened through UV light exposure. Antioxidants are substances which are able to essentially “neutralize” ROS in the body by binding to them so that they are no longer reactive and able to cause damage. There is some evidence to suggest that using skin cream containing antioxidants can help to slow down skin aging. The aim of this study is to investigate the effects of a cosmetic cream which contains antioxidants.
Who can participate?
Healthy Caucasian adults who are showing signs of skin ageing and have not had sun exposure on their backs for at least two months.
What does the study involve?
For all participants, four areas on the left and right legs are randomly allocated to have a different treatment applied every day for 30 days. The first treatment is the test cream, which contains a base with vitamin A, a vitamin E precursor (compound which reacts to form vitamin E) and glycyl glycineoleamide ( a molecule which protects skin tissue from wrinkles). The second treatment is a base cream containing 2% vitamin E. The third treatment is a placebo (dummy) cream which is made up of a base with no active ingredient, and the fourth treatment involves no cream being applied. Participants attend study visits after 15 and 30 days at which UVA radiation is applied to the test areas. Samples are then take four and 24 hours after the UVA application to measure antioxidant activity and fat breakdown.
What are the possible benefits and risks of participating?
There are no known benefits or risks involved with participating in this study.
Where is the study run from?
Farcoderm facilities, San Martino Siccomario (Italy)
When is the study starting and how long is it expected to run for?
March 2012 to July 2012
Who is funding the study?
Pierre Fabre Dermo Cosmétique (France)
Who is the main contact?
Dr Virginie Ribet
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RV4400A2011625
Study information
Scientific title
Placebo/benchmark-controlled, randomized, double blind clinical study aimed to evaluate in situ the antioxidant efficacy of a cosmetic product
Acronym
Study hypothesis
The aim of the study is to evaluate the antioxidant efficacy of a cosmetic product in situ.
Ethics approval
Not provided at time of registration.
Study design
Single-centre double-blind randomised placebo- and active-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Antioxidant efficacy of a cosmetic product
Intervention
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.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Antioxidant activity is measured using Fluorescence Recovery After Photobleaching (FRA) at baseline, 15 and 30 days.
Secondary outcome measures
Lipid peroxidation is measured by completing a Lipid Peroxidation (MDA) Assay in each area at baseline, 15 and 30 days of cream application.
Overall trial start date
13/03/2012
Overall trial end date
12/07/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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)
Recruitment start date
13/03/2012
Recruitment end date
30/04/2012
Locations
Countries of recruitment
Italy
Trial participating centre
Farcoderm facilities
Via Mons
Angelini, 21
San Martino Siccomario
27028
Italy
Funders
Funder type
Industry
Funder name
Pierre Fabre Dermo Cosmétique
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in JAMA Dermatology in 2016
Intention to publish date
30/01/2016
Participant level data
Available on request
Basic results (scientific)
Publication list