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CompletedNCT02831478Updated Dec 12, 2018

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

An interventional study of BAY987517 and Sunscreen Lotion (RB# T78-190B) in Sunscreening Agent, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 3 Years to 9 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-12.

Sponsored by Bayer · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
98
Allocation
Randomized
Ages
3 Years to 9 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Sunscreening Agent
03

In context

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 9 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
98 participants (actual)

Study arms

  • Experimental
    BAY987517

    2/3 of subjects testing the test article

    Drug: BAY987517

  • Active comparator
    Sunscreen Lotion

    1/3 of subjects testing the marketed control

    Drug: Sunscreen Lotion (RB# T78-190B)

Interventions

  • DrugBAY987517

    Applied liberally to the skin (Formulation: RB# Z16-071)

  • DrugSunscreen Lotion (RB# T78-190B)

    Applied liberally to the skin

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • Saint Petersburg, Florida 33714, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02831478
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Jul 13, 2016
Start date
Jul 9, 2016
Primary completion
Jul 10, 2016
Completion
Jul 10, 2016
Last update
Dec 12, 2018

Study contacts

Bayer Study Director
study director · Bayer

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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