Sunscreening Agents Clinical Trial
Official title:
Supervised Outdoor -Use Test for Sunscreen Products in Female Adults
Verified date | December 2018 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To assess the safety of a sunscreen product when used outdoor.
Status | Completed |
Enrollment | 105 |
Est. completion date | September 27, 2015 |
Est. primary completion date | September 27, 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 | After approximately three hours direct sun-exposure |
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