Photoprotective Effects of a SPF50+ Sunscreen on Skin Genotoxicity Induced by Repeated Chronic Outdoor Sun Exposure

NCT05926791 | Completed

• 1 other identifier: DNAOUTDOOR
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sun Damaged Skin

Keywords

Sunscreen; Chromametry and pigmentation; Suction blister; Liquid chromatography-High resolution Mass spectrometry; Mass spectrometry lipid analysis; Urine

Outcome Measures

Primary Outcomes (5)

• 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)

Study Arms (2)

Educated group with product

Subjects receiving the SPF50+ sunscreen product and a targeted educational action * Route of administration: Topical * Application duration: from 5 up to 21 days * Application modalities: The investigational product will be applied during the outdoor sun exposure on all exposed parts of the body (face and body). The investigational product will be applied in sufficient amount to cover the exposed areas (2mg/cm2 recommended), 15 to 30 minutes before each sun exposure. The product should be reapplied as many times as required during sun exposure (systematic reapplication of the product after sweating and/or swimming and/or wiping).

Other: Cosmetic product

Control group

Subjects receiving neither product nor targeted education

Interventions

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

Educated group with product

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• Male or female adults aged between 18 and 55 years included
• Subject with a habit of using little or no sunscreen products with low protection index (SPF \< 25) during sun exposure.
• Subject's commitment to have a self-reported sun exposure of at least 3 hours per day for the 5 days of their last week of vacation
• Subjects agreeing not to expose themselves to UVs (natural or artificial) before the planned outdoor sun exposure period

You may not qualify if:

• \- Criteria related to the population:
• Smoker of more than 10 cigarettes per day containing nicotine, paper and/or electronic cigarette equivalent
• \- Criteria related to the diseases / skin condition:
• Subject with a known history of photosensitivity (toxic, allergic)
• Subject with a known personal or family history of skin cancer
• Subject having hereditary or acquired disorders of hemostasis.
• \- Criteria related to the treatments and/or products:
• Systemic or topical treatment with photosensitizing or phototoxic potential (NSAIDs, antihistamines, psychotropic drugs, antidepressants, anti-migraine drugs, cyclines, quinolone, antibiotics, beta-blockers, etc.), taken or applied to the study area within the previous weeks, ongoing or planned during the study, and likely to interfere with the study according to the investigator's assessment
• Subject taking creatine dietary supplements and/or practicing prolonged fasting

Sponsors & Collaborators

• Pierre Fabre Dermo Cosmetique: lead

Study Sites (1)

Skin Research Center

Toulouse, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

urine

MeSH Terms

Interventions

Cosmetics

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Household Products; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: July 3, 2023
• Study Start: June 28, 2021
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

FR (1)