Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) - Assay

Sun Protection Factor (SPF) / UVA Protection Factor (UVAPF) 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 987516

• Study Type: Interventional
• Enrollment (Actual): 11
• 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: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

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 included 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 987516; 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	Measure Description	Time Frame
Evaluation of water resistant SPF	For the sunscreen Test Material, two test sites were used; one for before immersion and one for after 2 hours of water immersion. One additional test site area was used for the control SPF determination, on each subject, as per the COLIPA Sun Protection Factor Test Method.	16-24 hours post exposure

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 26, 2015
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (ESTIMATE): August 19, 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: 18321

Drug and device information, study documents

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