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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.
 
ClinicalTrials.gov Identifier: NCT01888887
Recruitment Status : Completed
First Posted : June 28, 2013
Last Update Posted : June 28, 2013
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Tracking Information
First Submitted Date  ICMJE June 26, 2013
First Posted Date  ICMJE June 28, 2013
Last Update Posted Date June 28, 2013
Study Start Date  ICMJE December 2012
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Repeat Insult Patch Test of Skin Irritation/Sensitization for Cetaphil Daily Facial Cleanser
Official Title  ICMJE Cetaphil Daily Facial Cleanser: 200 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation
Brief Summary Determine if Cetaphil Daily Facial Cleanser is a contact sensitizer or irritant to the skin
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Skin Irritation
Intervention  ICMJE Other: Cetaphil Daily Facial Cleanser
Study Arms  ICMJE Experimental: Cetaphil Daily Facial Cleanser
All subjects receive Cetaphil Daily Facial Cleanser
Intervention: Other: Cetaphil Daily Facial Cleanser
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2013)
200
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888887
Other Study ID Numbers  ICMJE GLI.04.SRE.US10236
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Galderma Laboratories, L.P.
Study Sponsor  ICMJE Galderma Laboratories, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mayya Tastene, MD AMA Laboratories
PRS Account Galderma Laboratories, L.P.
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP