check_circleStudy Completed

Sunscreening Agents

Bayer Identifier:

18803

ClinicalTrials.gov Identifier:

NCT02877511

EudraCT Number:

Not Available

EU CT Number:

Not Available
Supervised Outdoor-Use Test For Sunscreen Products in Adults

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - Subject must be healthy, males or females between 18 to 65 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
102
Trial Dates
August 2016 - August 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

Supervised Outdoor-Use Test For Sunscreen Products in Adults
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
Single Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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