Sunscreening Agents
Conditions
Brief summary
To evaluate the Sun Protection Factor efficacy on human skin.
Interventions
DRUGBAY987521
Each 50 cm\*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm\*2 test application. (Formulation number - Y49-103)
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. * Male and female * Aged between 18-70 years old. * Good health as determined from the HRL SHF (Subject History Form) * Signed and dated Informed Consent Form * Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. * An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)
Exclusion criteria
* Subjects on test at any other research laboratory or clinic. * Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. * Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. * Pre-existing other medical conditions (e.g. adult asthma. diabetes). * Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. * Treatment with antibiotics within two weeks prior to initiation of the test. * Chronic medication which could affect the results of the study. * Known pregnant or nursing women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Erythema Dose (MED) | Up to 15 minutes |
| Minimal Persistent Pigment Darkening Dose (MPPD) | Up to 15 minutes |
Countries
United States
Outcome results
None listed