check_circleStudy 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
  • - 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.


  • - 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
July 2016 - July 2016
Phase
N/A
Could I Receive a placebo
No
Products
BAY987517
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
St. Petersburg, 33714, United States

Primary Outcome

  • Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3
    date_rangeTime Frame:
    From the beginning of the study until 24 hours after study
    enhanced_encryption
    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
2

Additional Information

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