Study 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

Inclusion Criteria
- 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.
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

102

Trial Dates

August 2016 - August 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

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

Additional Information

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