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Trial record 1 of 1 for:    NCT00680095
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Cumulative Irritation Test

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: NCT00680095
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : April 9, 2019
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE May 15, 2008
First Posted Date  ICMJE May 19, 2008
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE January 22, 2007
Actual Primary Completion Date February 19, 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2008)
Severe irritation (Grade 3 or 4) observed at any site [ Time Frame: Daily for 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00680095 on Archive Site
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 Cumulative Irritation Test
Official Title  ICMJE 21-day Cumulative Irritation Test
Brief Summary The purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Detailed Description Healthy, adult volunteers of either sex will be patched on his/her back with AN2690 Solution 2.5%, AN2690 Solution 5%, AN2690 Solution 7.5%, AN2690 Solution Vehicle and Sodium Laurel Sulfate 0.5% over the course of 21 consecutive days. After 24 hours, the patches are to be removed and the site evaluated using a five-point scale for irritation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Onychomycosis
Intervention  ICMJE
  • Drug: AN2690
    AN2690 Solution, 2.5%, Daily for up to 21 days
  • Drug: AN2690
    AN2690 Solution, 7.5%, Daily for up to 21 days
  • Drug: AN2690
    AN2690 Solution, 5.0%, Daily for up to 21 days
  • Other: AN2690 Solution, Vehicle
    AN2690 Solution, Vehicle, Daily for up to 21 days
  • Other: Sodium Lauryl Sulfate, 0.5%
    Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Study Arms  ICMJE
  • Experimental: A
    AN2690 Solution, 2.5%
    Intervention: Drug: AN2690
  • Experimental: B
    AN2690 Solution, 7.5%
    Intervention: Drug: AN2690
  • Experimental: C
    AN2690 Solution, 5.0%
    Intervention: Drug: AN2690
  • Active Comparator: D
    AN2690 Solution, Vehicle
    Intervention: Other: AN2690 Solution, Vehicle
  • Active Comparator: E
    Sodium Lauryl Sulfate, 0.5%
    Intervention: Other: Sodium Lauryl Sulfate, 0.5%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2008)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 19, 2007
Actual Primary Completion Date February 19, 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy, volunteers of either sex, at least 18 years of age or older
  • Females of childbearing potential submitted to a urine pregnancy test and had negative results at Day 1 and at the final visit and also was using an effective method of birth control (e.g. abstinence, implants, injectables, oral contraceptives, intrauterine contraceptive devices or double barrier) or agreed to use an effective method of birth control prior to becoming sexual active
  • Subjects were of any skin type or race providing their degree of pigmentation did not interfere with making readings of skin reactions
  • Subjects were willing to follow the study procedures and complete the study
  • Written informed consent was obtained

Exclusion Criteria:

  • Subject with any skin disease that would have in any way confounded interpretation of the study results. Atopic dermatitis/eczema, psoriasis or chronic asthma were excluded
  • Subject was pregnant or nursing
  • Subject had a history of sensitivity to any component of any of the formulations
  • Use of chronic medications (such as antihistamines, corticosteroids, analgesics and anti-inflammatories) for one week before and during the study
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 NCT00680095
Other Study ID Numbers  ICMJE AN2690-ONYC-101
C3371011 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer Call Center Pfizer
PRS Account Pfizer
Verification Date April 2019

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