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Cumulative Irritation Test

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Onychomycosis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00680095
Pfizer
Completed
Cumulative Irritation Test

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Descriptive Information
Brief Title  ICMJE Cumulative Irritation Test
Official Title  ICMJE 21-day Cumulative Irritation Test
Brief SummaryThe purpose of this study is to determine the cumulative irritation potential of the products listed by the Sponsor.
Detailed DescriptionHealthy, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2008)
37
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 19, 2007
Actual Primary Completion DateFebruary 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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