Supervised Outdoor-Use Test to Assess the Safety of a Sunscreen C-Spray on Sport Users

Not Applicable

Completed

• Conditions: Sunscreen Agents
• Interventions: Drug: BAY 987519, SPF 50, Y51-002; Drug: BAY 987519, SPF 50, P04-147

• Registration Number: NCT02857478
• Lead Sponsor: Bayer

Brief Summary

The objective of this study was to assess the safety and appropriateness of a sunscreen product for use on sport users, under supervised outdoor-use conditions. The study was conducted under the supervision of a Board-Certified Dermatologist at an outdoor, chlorinated swimming pool facility.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-27
• Primary Completion: 2015-06-28
• Study Completion: 2015-06-28
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-04
• Study First Posted: 2016-08-05
• 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

• Male or female subjects, aged 18 to 65 years
• No actinic keratosis, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions
• Must not have visible erythema, blistering or peeling that would indicate recent sunburn
• Must not have asthma. Must not be undergoing therapy with system or topical corticosteroids, anti-inflammatories or antihistamine agents
• Must not be taking any medication in which exposure to the sun is contraindicated
• Must be willing to obey all rules of the test facility

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Safety of a Sunscreen product	BAY 987519, SPF 50, Y51-002	Sunscreen product safety evaluation under supervised out-door conditions on sport users.
Safety of a Sunscreen product	BAY 987519, SPF 50, P04-147	Sunscreen product safety evaluation under supervised out-door conditions on sport users.

Primary Outcome Measures

Name	Time	Method
Evaluation of AEs, including eye stinging	approximately 24 hours	Reported as product related or likely product related by the investigator or trained designee
Evaluation of Erythema as graded on a 5 point scale.	approximately 24 hours