Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

Conditions
-----------------
Sunscreening Agent

Intervention / Treatment
-----------------
* Drug: BAY987517


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>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<br>* Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)<br>|

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 |