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

To Assess the Safety of a Sunscreen Product,BAY 987519, Bayer Sponsored, CC Products

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 Overview

• Status: Completed
• Conditions: Sunscreen Agents
• Intervention / Treatment: Drug: BAY 987519, SPF 50, Y51-002; Drug: BAY 987519, SPF 50, P04-147

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33714

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety of a Sunscreen product; Sunscreen product safety evaluation under supervised out-door conditions on sport users.	Drug: BAY 987519, SPF 50, Y51-002; Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.; Drug: BAY 987519, SPF 50, P04-147; Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2015
• Primary Completion (Actual): June 28, 2015
• Study Completion (Actual): June 28, 2015

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 4, 2016
• First Posted (Estimate): August 5, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18317

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No