Clinical trial NCT02842268: Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Official title: Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agent
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-07-22
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent).
timeFrame: At baseline and post exercise (30 minutes)
Secondary outcomes:
measure: Eye Stinging on grading scale
timeFrame: Up to 30 mins
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
state: Florida
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: