Test the Outdoor Usage for Sunscreen Products in Female Adults

Supervised Outdoor -Use Test for Sunscreen Products in Female Adults

To assess the safety of a sunscreen product when used outdoor.

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Drug: BAY987518; Drug: Sunscreen Lotion (U77-030 Control)

• Study Type: Interventional
• Enrollment (Actual): 105
• 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: Female

Description

Inclusion Criteria:

• Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
• Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
• Subjects must agree to restrict their sun exposure activities for at least five days.
• Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.

Exclusion Criteria:

• Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
• Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
• Subjects must not have significantly tanned skin.
• Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BAY987518; Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again.	Drug: BAY987518; Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. Formulation: V27-104
ACTIVE_COMPARATOR: Sunscreen control; Subject will apply the test product to all sun exposed areas of face and body, wait for 15 minutes, then sunbathe for 30 minutes, exercise for 20 minutes, and then sunbathe for additional 30 minutes. Immediately after the second sunbathing, enter the pool and remain in the water for 20 minutes. Then repeat the sun and water exposure activities again.	Drug: Sunscreen Lotion (U77-030 Control); Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.

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	After approximately three hours direct sun-exposure

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 26, 2015
• Primary Completion (ACTUAL): September 27, 2015
• Study Completion (ACTUAL): September 27, 2015

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (ESTIMATE): May 20, 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

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 18318

Drug and device information, study documents

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