check_circleStudy Completed

Sunscreening Agents

Bayer Identifier:

18821

ClinicalTrials.gov Identifier:

NCT03002922

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluation of Sunscreen During Exercise Under Conditions of Profuse Sweating (821/2016)

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.

  • 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.

Trial summary

Enrollment Goal
17
Trial Dates
January 2017 - January 2017
Phase
N/A
Could I Receive a placebo
No
Products
BAY987517
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Hill Top ResearchSt. Petersburg, 33714, United States

Primary Outcome

  • Change of face coverage post exercise compared to the full coverage observed prior to exercise (in percent)
    The expert grader will determine the percentage of coverage achieved by viewing the subject’s face through the Skin Scanner
    date_rangeTime Frame:
    At baseline, and post exercise (30 minutes)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Report of eye stinging assessed by questionnaire
    Subjective assessment of eye stinging (where 0=none to 4=severe)
    date_rangeTime Frame:
    Up to 30 minutes
    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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