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Between 2 and 3 million non-melanoma skin cancers and 132,000 melanoma skin cancers occur globally each year. Sun protection continues to be a major public health issue and has always been a priority research area for Pierre Fabre laboratories. The involvement of ultraviolet radiation of the solar spectrum in skin carcinogenesis is well known, through its ability to damage the DNA of skin cells and the induction of oxidative processes.
The aim of this exploratory study is to perform the quantification of:
This study will allow us to better understand and quantify the benefit of sunscreens on photoinduced cellular damage and their elimination in urine.
This trial is a monocentric, exploratory, randomized, controlled, open-label, parallel-group study conducted in healthy adult subjects.
The target population consists of subjects who are accustomed to using few products or using low protection index during sun exposure.
The study area is the whole body for sun exposure. The target areas are the face and forearms for the samplings and measurements.
In this design, in order not to impose any strong constraint to the subjects in terms of sun exposure, the duration of the exposure period is left free and can vary between 5 and 21 days. Within this window, subjects can freely determine their sun exposure episodes (choice of time slot, number and duration). However, subjects have to expose themselves for at least 3 hours /day, for 5 days in the week prior to visit 2 (which will be scheduled no more than 3 days after their last sun exposure).
The study includes 3 visits:
The period of outdoor sun exposure varies between 5 and 21 days depending on the duration planned by the subjects themselves. This is also the duration of application of the investigational product for the subjects in group 1.
Visit 1 can be performed up to 15 days before the beginning of the sun exposure period and visit 2 up to 3 days after the last sun exposure.
The duration of participation for a subject varies between 20 and 56 days (from inclusion to the end of the study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educated group with product | Subjects receiving the SPF50+ sunscreen product and a targeted educational action
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| |
| Control group | Subjects receiving neither product nor targeted education |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cosmetic product | Other | The educated group receives the cosmetic product SPF50+ according to the randomization list established at V1 and returns the products at V2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in photoinduced DNA damage products in urine samples before and after outdoor sun exposure | Quantitative analysis of photoinduced DNA damage products by high performance liquid chromatography-coupled to tandem Mass Spectrometry (HPLC/MS-MS) | Change from baseline (day 1) to visit 2 (occuring between day 7 to 39 depending on the duration of sun exposure) |
| Number of CPD (Cyclobutane Pyrimidine Dimer) lesions in epidermal samples collected from the forearm following the outdoor sun exposure period | Number of CPD (Cyclobutane Pyrimidine Dimer) lesions in epidermal samples by high performance liquid chromatography-coupled to tandem Mass Spectrometry (HPLC/MS-MS) | Day 7 to 39 (depending on the duration of sun exposure) |
| Change in colorimetric parameters before and after outdoor sun exposure | Colorimetric parameters assessed by chromametry on the face and forearm | Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure) |
| Change in pigmentation parameters before and after outdoor sun exposure | Pigmentation parameters assessed by Multispectral analysis on the face and forearms | Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure) |
| Change in cellular damages before and after outdoor sun exposure | Cellular damage assessed by Mass spectrometry lipid analysis in D-Squame samples collected on the face and forearm before and after outdoor sun exposure | Change from baseline (day 1) to visit 2 (between day 7 to 39 depending on the duration of sun exposure) up to visit 3 ( between day 20 to 56) |
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Inclusion Criteria:
Exclusion Criteria:
- Criteria related to the population:
- Criteria related to the diseases / skin condition:
- Criteria related to the treatments and/or products:
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Subjects will be recruited from the investigation centre's panel. The participants will be selected on the basis of inclusion and non-inclusion criteria specific to the study and on their ability to comply with the constraints required by the protocol. The participants will be definitely included in the study after a specific interview and a clinical examination
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Research Center | Toulouse | France |
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| ID | Term |
|---|---|
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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urine