18432-Sun Protection Factor Assay

NCT ID: NCT02779829

Last Updated: 2018-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-29
• Study Completion Date: 2015-09-01

Brief Summary

To evaluate the Sun Protection Factor efficacy on human skin.

Conditions

Sunscreening Agent

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Coppertone (BAY 987517)

Intervention Type: DRUG

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. Formulation number SR15-40-Z12-006.

Interventions

Coppertone (BAY 987517)

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. Formulation number SR15-40-Z12-006.

Intervention Type: DRUG

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
• Signed and dated Informed Consent Form
• Signed and dated 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Union, New Jersey, United States

Countries

United States

Other Identifiers

18432

Identifier Type: -

Identifier Source: org_study_id