Study Completed

Sunscreening Agent

Bayer Identifier:

18533

ClinicalTrials.gov Identifier:

NCT02831478

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

3 - 9 Years

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

Trial Dates

July 2016 - July 2016

Phase

N/A

Could I Receive a placebo

Products

BAY987517

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed		St. Petersburg, 33714, United States

Primary Outcome

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
Safety Issue:
Yes

Trial design

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

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Randomized

Blinding

Double Blind

Assignment

Parallel Assignment

Trial Arms

Additional Information

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