18612 - Sun Protection Factor Assay

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: BAY 987521

Study type: Interventional

Funder types: Industry

Identifiers

NCT02760576

18612

Details and patient eligibility

About

To evaluate the Sun Protection Factor efficacy on human skin.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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 Form (Health Insurance Portability and Accountability Act).
• An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

BAY 987521

Experimental group

Description:

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.

Treatment:

Drug: BAY 987521