Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) Assay
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 11
- Primary Endpoint
- Evaluation of water resistant SPF
Study Overview
Brief Summary
Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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).
Exclusion Criteria
- Not provided
Arms & Interventions
SPF evaluation
Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.
Intervention: BAY 987516 (Drug)
SPF evaluation
Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were included for SPF testing.
Intervention: SPF 15 Control (Drug)
Outcomes
Primary Outcomes
Evaluation of water resistant SPF
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported