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Patch Test Skin Irritation/Sensitization of Cetaphil Restoraderm Skin Restoring Body Wash

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.
 
ClinicalTrials.gov Identifier: NCT01892410
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : July 4, 2013
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:
Determine if Cetaphil Restoraderm Skin Restoring Body Wash proves to be a contact sensitizer or irritant in certain individuals.

Condition or disease Intervention/treatment Phase
Skin Irritation Other: Cetaphil Restoraderm Skin Restoring Body Wash Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Semi-Occlusive Patch)
Study Start Date : December 2012
Actual Primary Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Cetaphil

Arm Intervention/treatment
Experimental: Cetaphil Restoraderm Skin Restoring Body Wash
All subjects receive Cetaphil Daily Advance Ultra Hydrating Lotion
Other: Cetaphil Restoraderm Skin Restoring Body Wash
Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks




Primary Outcome Measures :
  1. Area of irritation measured to determine sensitivity [ Time Frame: 3 weeks ]
    9 consecutive 24hr exposures for every Monday, Wednesday, and Friday for 3 consecutive weeks



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

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 ClinicalTrials.gov identifier (NCT number): NCT01892410


Locations
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United States, New York
AMA Laboratories, Inc.
New City, New York, United States, 10956
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
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Principal Investigator: Mayya Tastene, MD AMA Laboratories

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Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT01892410     History of Changes
Other Study ID Numbers: GLI.04.SRE.US10235
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: June 2013