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Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old

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: NCT02831478
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer

Condition or disease Intervention/treatment Phase
Sunscreening Agent Drug: BAY987517 Drug: Sunscreen Lotion (RB# T78-190B) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
Actual Study Start Date : July 9, 2016
Actual Primary Completion Date : July 10, 2016
Actual Study Completion Date : July 10, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sun Exposure

Arm Intervention/treatment
Experimental: BAY987517
2/3 of subjects testing the test article
Drug: BAY987517
Applied liberally to the skin (Formulation: RB# Z16-071)

Active Comparator: Sunscreen Lotion
1/3 of subjects testing the marketed control
Drug: Sunscreen Lotion (RB# T78-190B)
Applied liberally to the skin




Primary Outcome Measures :
  1. Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 [ Time Frame: From the beginning of the study until 24 hours after study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject must be healthy, males or females between 3 to 9 years of age with no medical conditions of the skin.
  • Subjects must have Fitzpatrick Skin Type I, II, III or IV.
  • Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study.

Exclusion Criteria:

  • Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions.
  • Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation.
  • Subjects must not have significantly tanned skin.

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): NCT02831478


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: NCT02831478    
Other Study ID Numbers: 18533
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: December 12, 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
Additional relevant MeSH terms:
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Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Dermatologic Agents