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

Bayer98 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Sunscreen Agents

Interventions

BAY 987519, SPF 50, Y51-002DRUG

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

BAY 987519, SPF 50, P04-147DRUG

Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

St. Petersburg, Florida, United States

Outcomes

Primary Outcomes

Evaluation of Erythema as graded on a 5 point scale.

Time frame: approximately 24 hours

Evaluation of AEs, including eye stinging

Reported as product related or likely product related by the investigator or trained designee

Time frame: approximately 24 hours

Data from ClinicalTrials.gov

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