- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831478
Outdoor-Use Test for Sunscreen Products in Children Ages 3 to 9 Years Old
December 11, 2018 updated by: Bayer
To assess the safety of a sunscreen product under supervised outdoor-use conditions with the target consumer
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
98
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Saint Petersburg, Florida, United States, 33714
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 9 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BAY987517
2/3 of subjects testing the test article
|
Applied liberally to the skin (Formulation: RB# Z16-071)
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ACTIVE_COMPARATOR: Sunscreen Lotion
1/3 of subjects testing the marketed control
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Applied liberally to the skin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
From the beginning of the study until 24 hours after study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 9, 2016
Primary Completion (ACTUAL)
July 10, 2016
Study Completion (ACTUAL)
July 10, 2016
Study Registration Dates
First Submitted
July 11, 2016
First Submitted That Met QC Criteria
July 11, 2016
First Posted (ESTIMATE)
July 13, 2016
Study Record Updates
Last Update Posted (ACTUAL)
December 12, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18533
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sunscreening Agent
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BayerCompleted
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BayerCompletedSunscreening AgentUnited States
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BayerCompleted