Sunscreening Agents
Conditions
Brief summary
To assess the safety of a sunscreen product when used outdoor.
Interventions
DRUGBAY987518
Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids. Formulation: V27-104
DRUGSunscreen Lotion (U77-030 Control)
Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
Sponsors
Bayer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 | After approximately three hours direct sun-exposure |
Countries
United States
Outcome results
None listed