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Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842268
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment Phase
Sunscreening Agent Drug: BAY987517 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating
Actual Study Start Date : June 17, 2016
Actual Primary Completion Date : June 22, 2016
Actual Study Completion Date : June 22, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BAY987517
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
Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Eye Stinging on grading scale [ Time Frame: Up to 30 mins ]
    On scale:0 = None,1 = Slight,2 = Mild,3 = Moderate, 4 = Severe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842268


Locations
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United States, Florida
Saint Petersburg, Florida, United States, 33714
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02842268    
Other Study ID Numbers: 18818
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No