NCT02936570CompletedNot Applicable
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 5
- Primary Endpoint
- Minimal Erythema Dose (MED)
Study Overview
Brief Summary
To evaluate the Sun Protection Factor efficacy on human skin.
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
- •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.
Arms & Interventions
BAY987521
Experimental
Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, 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.
Intervention: BAY987521 (Drug)
Outcomes
Primary Outcomes
Minimal Erythema Dose (MED)
Time Frame: Up to 15 minutes
Minimal Persistent Pigment Darkening Dose (MPPD)
Time Frame: Up to 15 minutes
Secondary Outcomes
No secondary outcomes reported
Investigators
Similar Trials
Completed
Not Applicable
18612 - Sun Protection Factor AssaySunscreening AgentsNCT02760576Bayer10
Completed
Not Applicable
Sun Protection Factor AssaySunscreening AgentsNCT02815241Bayer5
Completed
Not Applicable
Sun Protection Factor Assay (339/2016)Sunscreening AgentsNCT02995122Bayer10
Completed
Not Applicable
18616 - Sun Protection Factor AssaySunscreening AgentNCT02788162Bayer10
Completed
Not Applicable
Sun Protection Factor Assay (338/2016)Sunscreening AgentsNCT02995109Bayer10