18432-Sun Protection Factor Assay (SPF Assay)

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

To evaluate the Sun Protection Factor efficacy on human skin.

Study Overview

• Status: Completed
• Conditions: Sunscreening Agent
• Intervention / Treatment: Drug: Coppertone (BAY 987517)

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Union, New Jersey, United States, 07083

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Minimal Erythema Dose (MED)	Up to 15 minutes
Minimal Persistent Pigment DArkening Dose (MPPD)	Up to 15 minutes

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 19, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 18432 (Other Identifier: City of Hope Medical Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No