Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY987517

• Registration Number: NCT03002922
• Lead Sponsor: Bayer

Brief Summary

To visually evaluate the retention of coverage of the Test Product(s) (TP) on the face after exercise compared to the full coverage observed prior to exercise

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Study Start: 2017-01-18
• Primary Completion: 2017-01-28
• Study Completion: 2017-01-28
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Subjects may be male or female, of an age of 18-55 years inclusive. Subjects must be capable of understanding and providing written informed consent.

Subjects must sign a written confidentiality agreement including a photography release form.

Subjects must be in good general health as judged by a specified licensed physician, who will indicate their suitability to participate in this study.

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Exclusion Criteria

Subjects must not have received or used an Investigational New Drug within the last 30 days.

Subjects must not have been active participants in another clinical or subjective TP performance study within the last 30 days unless authorized by this Sponsor. Subjects must not have a known physical or medical condition that would preclude vigorous exercise Subjects must not have a five-minute resting pulse rate greater than 80 bpm.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy subjects	BAY987517	Subject will self-apply the test sunscreen formula to his/her face with the goal of applying 0.65 to 0.85 grams. Subject should sweat profusely.

Primary Outcome Measures

Name	Time	Method
Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)	At baseline, and post exercise (30 minutes)	The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner

Secondary Outcome Measures

Name	Time	Method
Report of eye stinging assessed by questionnaire	Up to 30 minutes	Subjective assessment of eye stinging (where 0=none to 4=severe)

Trial Locations

Locations (1)

Hill Top Research; 🇺🇸 Saint Petersburg, Florida, United States