Test the Outdoor Usage for Sunscreen Products in Female Adults

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY987518; Drug: Sunscreen Lotion (U77-030 Control)

• Registration Number: NCT02779270
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-26
• Primary Completion: 2015-09-27
• Study Completion: 2015-09-27
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BAY987518	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.
Sunscreen control	Sunscreen Lotion (U77-030 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.

Primary Outcome Measures

Name	Time	Method
Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3	After approximately three hours direct sun-exposure