18751-Sun Protection Factor Assay. (SPF Assay)

Bayer

Status: Completed

Conditions: Sunscreening Agents

Treatments: Drug: Coppertone(BAY987517)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02739802

18751

Details and patient eligibility

About

To evaluate the Sun Protection Factor (SPF) efficacy on human skin.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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 or female - Aged between 18-70 years old. - Good health - Signed and dated Informed Consent Form - Signed and dated Health Insurance Portability and Accountability Authorization (HIPAA) Form - An unambiguous MED 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

BAY 987517

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: Coppertone(BAY987517)