Sun Protection Factor (SPF) Assay

Evaluation of the effectiveness of a sunscreen product by determining its Sun Protection Factor (SPF) on the skin of human subjects.

Study Overview

• Status: Completed
• Conditions: Sunscreen Agents
• Intervention / Treatment: Drug: SPF 15 Control; Drug: BAY 987517

• Study Type: Interventional
• Enrollment (Actual): 12
• 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:

• Male or female of an age of 18 to 70 years inclusive;
• Fitzpatrick Skin Type I, II and/or III for SPF testing;
• Good health as determined from the CRO Subject History Form (SHF);
• Signed and dated Informed Consent Form;
• Signed and dated Health Insurance Portability and Accountability Act (HIPAA) Form;
• An unambiguous minimal erythema dose (MED).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• 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: SPF evaluation; Subjects with good health as determined from the CRO Subject History Form (SHF) and Fitzpatrick Skin Type I, II and/or III were considered for SPF testing.	Drug: SPF 15 Control; Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.; Drug: BAY 987517; Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of water resistant SPF in accordance to 21 CFR (Code of Federal Regulations) 207.327	16-24 h post exposure

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2015
• Primary Completion (Actual): June 9, 2015
• Study Completion (Actual): June 9, 2015

Study Registration Dates

• First Submitted: July 29, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 5, 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: 18300

Drug and device information, study documents

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