Sun Protection Factor (SPF) - Static and Water Resistant Assay

December 11, 2018 updated by: Bayer
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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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: BAY 987519
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of water resistant SPF in accordance to ISO 24444
Time Frame: 16-24 hrs post exposure
16-24 hrs post exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2015

Primary Completion (Actual)

June 10, 2015

Study Completion (Actual)

June 10, 2015

Study Registration Dates

First Submitted

August 3, 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

  • 18320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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