Supervised Outdoor-Use Test For Sunscreen Products in Adults
Not Applicable
Completed
- Conditions
- Sunscreening Agents
- Interventions
- Drug: BAY987517Drug: Sunscreen Lotion (Y65-110)
- Registration Number
- NCT02877511
- Lead Sponsor
- Bayer
- Brief Summary
To assess the safety of a sunscreen product under supervised outdoor-use conditions
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
Inclusion Criteria
- Subject must be healthy, males or females between 18 to 65 years of age with no medical conditions of the skin.
- Subjects must have Fitzpatrick Skin Type I, II, III or IV.
- Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.
Exclusion Criteria
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
- Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
- Subjects must not have significantly tanned skin.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 BAY987517 2/3 of subjects testing the test article Arm 2 Sunscreen Lotion (Y65-110) 1/3 of subjects testing the marketed control
- Primary Outcome Measures
Name Time Method Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 From the beginning of the study until 24 hours after study
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of BAY987517 in UV protection and skin health?
How does Sunscreen Lotion (Y65-110) compare to standard-of-care sunscreens in photoprotection efficacy?
Are there specific biomarkers that correlate with enhanced photoprotection using BAY987517?
What adverse events are associated with BAY987517 application in outdoor conditions?
What related compounds or formulations is Bayer developing for UV protection alongside BAY987517?