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.

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Key information

Conditions

Sunscreening Agent

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Petersburg, Florida, 33714, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY987517

Drug

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

Primary outcomes

Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).

Time frame: At baseline and post exercise (30 minutes)

Done with a Skin Scanner( before and after each exercise session) using the 11-point scale

Secondary outcomes

Eye Stinging on grading scale

Time frame: Up to 30 mins

On scale:0 = None,1 = Slight,2 = Mild,3 = Moderate, 4 = Severe

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jul 22, 2016
Registry last updated: Dec 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed