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Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01888887
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:
Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin

Condition or disease Intervention/treatment Phase
Skin Irritation Other: Cetaphil Daily Facial Cleanser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Cetaphil Daily Facial Cleanser: 200 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation
Study Start Date : December 2012
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cetaphil

Arm Intervention/treatment
Experimental: Cetaphil Daily Facial Cleanser
All subjects receive Cetaphil Daily Facial Cleanser
Other: Cetaphil Daily Facial Cleanser

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01888887

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United States, New York
AMA Laboratories
New City, New York, United States, 10956
Sponsors and Collaborators
Galderma Laboratories, L.P.
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Principal Investigator: Mayya Tastene, MD AMA Laboratories
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Responsible Party: Galderma Laboratories, L.P. Identifier: NCT01888887    
Other Study ID Numbers: GLI.04.SRE.US10236
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: June 28, 2013
Last Verified: June 2013