Supervised Outdoor-Use Test For Sunscreen Products in Adults

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY987517; Drug: 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

Study Timeline

• Study First Submitted: 2016-08-19
• Study First Submitted QC: 2016-08-19
• Study Start: 2016-08-20
• Primary Completion: 2016-08-21
• Study Completion: 2016-08-21
• Study First Posted: 2016-08-24
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13

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