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

Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

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

Study Overview

• Status: Completed
• Conditions: Sunscreening Agents
• Intervention / Treatment: Drug: BAY987517

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Petersburg, Florida, United States, 33714
      • Hill Top Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy subjects; 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.	Drug: BAY987517; Sunscreen formula Y65-158

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report of eye stinging assessed by questionnaire	Subjective assessment of eye stinging (where 0=none to 4=severe)	Up to 30 minutes

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): January 28, 2017
• Study Completion (Actual): January 28, 2017

Study Registration Dates

• First Submitted: December 19, 2016
• First Submitted That Met QC Criteria: December 21, 2016
• First Posted (Estimate): December 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18821

Drug and device information, study documents

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