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

Bayer

Status: Completed

Conditions: Sunscreen Agents

Treatments: Drug: BAY 987519, SPF 50, P04-147; Drug: BAY 987519, SPF 50, Y51-002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02857478

18317

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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98 participants in 1 patient group

Safety of a Sunscreen product

Experimental group

Description:

Sunscreen product safety evaluation under supervised out-door conditions on sport users.

Treatment:

Drug: BAY 987519, SPF 50, Y51-002

Drug: BAY 987519, SPF 50, P04-147