Photoprotective Effects of a SPF50+ Sunscreen on Skin Genotoxicity Induced by Repeated Chronic Outdoor Sun Exposure
Condition: Sun Damaged Skin
Study type: Observational

Summary: 
      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:

        -  DNA photoproducts excised from the genome by the biological repair systems in urine
           samples

        -  cellular DNA damage in the epidermis following chronic exposure to natural sunlight.

      This study will allow us to better understand and quantify the benefit of sunscreens on
      photoinduced cellular damage and their elimination in urine.
    

Detailed description: 
      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:

        -  Visit 1: Inclusion (D1)

        -  Visit 2: Intermediate visit (D7 to D39)

        -  Visit 3: Wound healing evaluation and end of study (V2 + 15 days +/- 2 days)

      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).
    

Intervention name(s): Cosmetic product
Intervention type(s): Other
Intervention description(s): The educated group receives the cosmetic product SPF50+ according to the randomization list established at V1 and returns the products at V2
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        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
      
Biospecimen description: 
      urine
    
Keywords: Sunscreen; Chromametry and pigmentation; Suction blister; Liquid chromatography-High resolution Mass spectrometry; Mass spectrometry lipid analysis; Urine