Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

Not Applicable

Completed

• Conditions: Sunscreening Agent
• Interventions: Drug: BAY987517; Drug: Sunscreen Lotion (RB# T78-190B)

• Registration Number: NCT02831478
• Lead Sponsor: Bayer

Brief Summary

To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-09
• Primary Completion: 2016-07-10
• Study Completion: 2016-07-10
• Study First Submitted: 2016-07-11
• Study First Submitted QC: 2016-07-11
• Study First Posted: 2016-07-13
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Subject must be healthy, males or females between 3 to 9 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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY987517	BAY987517	2/3 of subjects testing the test article
Sunscreen Lotion	Sunscreen Lotion (RB# T78-190B)	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