Supervised Outdoor-Use Test For Sunscreen Products in Adults

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

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Drug: BAY987517; Drug: Sunscreen Lotion (Y65-110)

• Study Type: Interventional
• Enrollment (Actual): 102
• 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:

• Subject must be healthy, males or females between 18 to 65 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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1; 2/3 of subjects testing the test article	Drug: BAY987517; Applied liberally to the skin (Formulation: Y73-161
Active Comparator: Arm 2; 1/3 of subjects testing the marketed control	Drug: Sunscreen Lotion (Y65-110); Applied liberally to the skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2016
• Primary Completion (Actual): August 21, 2016
• Study Completion (Actual): August 21, 2016

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 19, 2016
• First Posted (Estimate): August 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 18803

Drug and device information, study documents

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