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 Agent
• Intervention / Treatment: Drug: BAY987517

• Study Type: Interventional
• Enrollment (Actual): 15
• 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 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.
• Female subjects must be willing to take a rapid screen pregnancy test prior to each exercise session.
• Subjects must be willing to follow study instructions as set forth in the protocol.
• Subjects must not have facial piercing(s).
• Subjects must be Fitzpatrick Skin Type I, II, or III.

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.
• Subjects must not take any chronic medication other than vitamins, hormone replacement therapy, low-dose aspirin, or oral contraceptives.
• Subjects must not have applied prescription or over-the-counter medicines to their face at least 96 hours prior to exercise session
• Subjects must not have a known allergy or sensitivity to sunscreen products or Cetaphil cleanser.
• Female subjects must not be pregnant (self-reported) or test positive using an on-site pregnancy test.
• Female subjects must not be nursing a child.
• Subjects must not have smoked cigarettes, pipes, or cigars in the last 60 days.
• Subjects who in the judgment of the Investigator have any condition that would make study participation inappropriate.
• Subjects must not be a member or relative of the clinical trial staff or the Sponsor directly involved in the study.

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: 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.	Drug: BAY987517; Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)

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).	Done with a Skin Scanner( before and after each exercise session) using the 11-point scale	At baseline and post exercise (30 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye Stinging on grading scale	On scale:0 = None,1 = Slight,2 = Mild,3 = Moderate, 4 = Severe	Up to 30 mins

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2016
• Primary Completion (Actual): June 22, 2016
• Study Completion (Actual): June 22, 2016

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18818

Drug and device information, study documents

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