Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

NCT02842268 | Completed

• 1 other identifier: 18818
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sunscreening Agent

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Eye Stinging on grading scale

  Up to 30 mins

Study Arms (1)

BAY987517

EXPERIMENTAL

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

Interventions

BAY987517 DRUG

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

BAY987517

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

St. Petersburg, Florida, 33714, United States

Location

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: July 22, 2016
• Study Start: June 17, 2016
• Primary Completion: June 22, 2016
• Study Completion: June 22, 2016
• Last Updated: December 13, 2018

Record last verified: 2018-12

Locations

US (1)