Sunscreen Agents
Conditions
Brief summary
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
Interventions
DRUGBAY 987516
Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
DRUGSPF 15 Control
Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
Sponsors
Bayer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female of an age of 18 to 70 years inclusive; * Fitzpatrick Skin Type I, II and/or III for SPF testing; * Good health as determined from the CRO Subject History Form (SHF); * Signed and dated Informed Consent Form; * Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form; * An unambiguous minimal erythema dose (MED).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of water resistant SPF | 16-24 hours post exposure | For the sunscreen Test Material, two test sites were used; one for before immersion and one for after 2 hours of water immersion. One additional test site area was used for the control SPF determination, on each subject, as per the COLIPA Sun Protection Factor Test Method. |
Countries
United States
Outcome results
None listed