Study Completed

Sunscreening Agents

Bayer Identifier:

18318

ClinicalTrials.gov Identifier:

NCT02779270

EudraCT Number:

Not Available

EU CT Number:

Not Available

Test the Outdoor usage for Sunscreen Products in Female Adults

Trial purpose

To assess the safety of a sunscreen product when used outdoor.

Key Participants Requirements

Sex

Female

Age

18 - 65 Years

Inclusion Criteria
- Subjects must be healthy, fair skinned females between the ages of 18 to 65 years with no medical conditions of the skin.
- Subjects must have Fitzpatrick Skin Types I, II, III, or IV.
- Subjects must agree to restrict their sun exposure activities for at least five days.
- Subjects must be willing and physically able to spend approximately 3 continous hours in the sun.
Exclusion Criteria
- Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions as determined by the dermatological medical history.
- Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn.
- Subjects must not have significantly tanned skin.
- Subjects must not have received any phototoxic agent or any medication to which they have a known sensitivity or allergy.

Trial summary

Enrollment Goal

105

Trial Dates

September 2015 - September 2015

Phase

N/A

Could I Receive a placebo

Products

BAY987518

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:
After approximately three hours direct sun-exposure
Safety Issue:
Yes

Trial design

Supervised Outdoor -Use Test for Sunscreen Products in Female 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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