Sun Protection Factor Assay (344/2016)

Not Applicable

Completed

• Conditions: Sunscreening Agents
• Interventions: Drug: BAY987521; Drug: SPF control

• Registration Number: NCT02995161
• Lead Sponsor: Bayer

Brief Summary

To evaluate the Sun Protection Factor efficacy on human skin.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-16
• Study Start: 2016-12-30
• Primary Completion: 2017-01-04
• Study Completion: 2017-01-04
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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).

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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 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPF evaluation	BAY987521	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.
SPF evaluation	SPF control	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.

Primary Outcome Measures

Name	Time	Method
Minimal Erythema Dose (MED)	Up to 15 minutes
Minimal Persistent Pigment Darkening Dose (MPPD)	Up to 15 minutes