Trial Condition(s):

Sunscreening Agent

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

Bayer Identifier:

18533

ClinicalTrials.gov Identifier:

NCT02831478

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
98
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
BAY987517
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

St. Petersburg, United States, 33714

Status
Completed
 

Trial Design