Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Dermacontrol Oil Control Moisturizer SPF 30

July 28, 2022 updated by: Galderma R&D

Cetaphil Dermacontrol Oil Control Moisturizer SPF 30- 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-occlusive Patch)

Determine if Cetaphil DermaControl Oil Control Moisturizer SPF 30 proves to be a contact sensitizer or irritant in certain individuals

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Not currently under a doctor's care
  • Free of dermatological or systemic disorder which would interfere with the results
  • Free of any acute or chronic disease
  • Will complete a preliminary medical history form and are in general good health
  • Can read, understand, and sign informed consent

Exclusion Criteria:

  • Under 18 years old
  • Currently under doctor's care
  • Currently taking any medication
  • History of acute or chronic disease
  • Diagnosed with chronic skin allergies
  • Pregnant or lactating

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cetaphil DermaControl Oil Control Moisturizer SPF 30
All subjects receive Cetaphil DermaControl Oil Control Moisturizer SPF 30
Other: Cetaphil DermaControl Oil Control Moisturizer SPF 30

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
area of erythema and edema to test reaction of skin to product
Time Frame: 3 consecutive weeks
9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks will be conducted to test the reaction of the skin to the test product
3 consecutive weeks

Collaborators and Investigators

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

Sponsor

Galderma R&D

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

December 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

June 21, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GLI.04.SRE.US10232b

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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