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

Sunscreening Agents Clinical Trial

Official title:

Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002922
• Other study ID #: 18821
• Status: Completed
• Phase: N/A
• First received: December 19, 2016
• Last updated: January 25, 2018
• Start date: January 18, 2017
• Est. completion date: January 28, 2017

Study information

• Verified date: January 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 28, 2017
• Est. primary completion date: January 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Sunscreening Agents

Intervention

Drug:
• BAY987517
Sunscreen formula Y65-158

Locations

Country	Name	City	State
United States	Hill Top Research	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)	The expert grader will determine the percentage of coverage achieved by viewing the subject's face through the Skin Scanner	At baseline, and post exercise (30 minutes)
Secondary	Report of eye stinging assessed by questionnaire	Subjective assessment of eye stinging (where 0=none to 4=severe)	Up to 30 minutes

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