check_circleStudy Completed

Sunscreening Agent

Bayer Identifier:

18818

ClinicalTrials.gov Identifier:

NCT02842268

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - 55 Years
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
15
Trial Dates
June 2016 - June 2016
Phase
N/A
Could I Receive a placebo
No
Products
BAY987517
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • 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
    date_rangeTime Frame:
    At baseline and post exercise (30 minutes)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Eye Stinging on grading scale
    On scale:0 = None,1 = Slight,2 = Mild,3 = Moderate, 4 = Severe
    date_rangeTime Frame:
    Up to 30 mins
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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