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Repeat Insult Patch Test for Daily Advance Cetaphil Moisturizing Lotion

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: NCT01892423
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : July 4, 2013
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

Brief Summary:
Human repeat insult patch test to assess the potential for Cetaphil Moisturizing Lotion Daily Advance to induce sensitization to the skin

Condition or disease Intervention/treatment Phase
Skin Irritation Other: Cetaphil Moisturizing Lotion Daily Advance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Daily Advance Cetaphil Moisturizing Lotion: Human Repeat Insult Patch Test
Study Start Date : August 2006
Actual Primary Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Cetaphil

Arm Intervention/treatment
Experimental: Cetaphil Moisturizing Lotion Daily Advance
Each subject had Cetaphil Moisturizing Lotion Daily Advance applied
Other: Cetaphil Moisturizing Lotion Daily Advance

Primary Outcome Measures :
  1. Irritation responses [ Time Frame: average of 5 weeks ]
    all patients will be assessed at 14 visits for redness (erythema), spreading, weeping, papules, vesicles, and bullae at application site

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 18-65 years
  • Good health
  • willingness to cooperate and participate
  • willingness to avoid topical products at test sites
  • willingness to avoid direct sun exposure to test sites

Exclusion Criteria:

  • Individuals with active psoriasis or eczema
  • individuals with sunburn, acne, abrasions, scar tissue, or tattoos on test sites, or disease of skin that might interfere
  • individuals who have had a mastectomy with axillary nodes were removed
  • individuals receiving anticancer, immunosuppressive treatments or medications, or radiation
  • pregnant, nursing, or planned to become pregnant
  • use of topical steroids or drugs at test sites
  • active or untreated skin cancer
  • active hepatitis
  • current routine or frequent use of high doses of anti-inflammatory drugs
  • individuals who have had les than two week rest period since completion of previous patch testing on upper back or upper arms
  • individuals with uncontrolled metabolic diseases

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): NCT01892423

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United States, Texas
Thomas J Stephens and Associates Inc
Carrollton, Texas, United States, 75006
Sponsors and Collaborators
Galderma Laboratories, L.P.
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Principal Investigator: James H Herndon, MD, FAAD

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Responsible Party: Galderma Laboratories, L.P. Identifier: NCT01892423     History of Changes
Other Study ID Numbers: GLI.04SPR.US10044
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: July 4, 2013
Last Verified: June 2013