Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay (UVAPF), Minimal Persistent Pigment-Darkening Dose (MPPD)

Bayer0 sites10 target enrollmentOctober 29, 2015

ConditionsSunscreening Agent

InterventionsCoppertone (BAY987517)

DrugsCoppertone (BAY987517)

Overview

Phase: Not Applicable
Intervention: Coppertone (BAY987517)
Conditions: Sunscreening Agent
Sponsor: Bayer
Enrollment: 10
Primary Endpoint: Minimal Erythema Dose (MED)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To evaluate the Sun protection factor efficacy on human skin.

Registry

clinicaltrials.gov

Start Date

October 29, 2015

End Date

November 5, 2015

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility Criteria

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(Self History Form)
•Signed and dated Informed Consent Form
•Signed and dated HIPAA (Health Insurance Portability and Accountability Act) Form
•An unbambiguous 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 diagnosed 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 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.
•Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.

Arms & Interventions

BAY987517

Each test site area is divided into test subsite 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: Coppertone (BAY987517)