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Cumulative Irritation Test

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NCT00781664

Last updated on November 14, 2019
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Study Location
The Education and Research Foundation, Inc.
Lynchburg, Virginia, 24501 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tinea Pedis
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

Subjects must meet all of the following criteria for inclusion in the study.

1. Healthy volunteers of either sex, at least 18 years of age or older.

2. Females must be of non-childbearing potential (i.e., post-menopausal or surgically
sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit
to a urine pregnancy test and have a negative result at Day 1 and at the final study
visit.

3. Subjects may be of any skin type or race providing their degree of skin pigmentation
does not interfere with making readings of skin reactions.

4. Willingness to follow the study procedures and complete the study.

5. Written informed consent obtained.

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

1. Any skin disease that would in any way confound interpretation of the study results.
Atopic dermatitis/eczema, psoriasis will be excluded.

2. Chronic asthma will be excluded.

3. Pregnant or nursing mothers.

4. A history of sensitivity to any component of any of the formulations.

5. Use of chronic medications (such as antihistamines, corticosteroids, analgesics and
anti-inflammatories) for one week before and during the study.

NCT00781664
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 daily on his/her back with multiple strengths of AN2718 in 2 different topical dosage forms and an active comparator over the course of 21 consecutive days. Twenty-four hours after each application, the patches will 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 Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Tinea Pedis
Intervention  ICMJE
  • Other: AN2718
    AN2718 Cream SF Vehicle, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Cream SF, 0.3%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Cream SF, 1%, Daily for up to 21 days
  • Other: AN2718
    AN2718 Gel Vehicle, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 1.5%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 2.5%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 5%, Daily for up to 21 days
  • Drug: AN2718
    AN2718 Gel, 7.5%, Daily for up to 21 days
  • Other: Sodium Lauryl Sulfate
    Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
    Other Name: SLS
Study Arms  ICMJE
  • Experimental: A
    AN2718 Cream SF Vehicle
    Intervention: Other: AN2718
  • Experimental: B
    AN2718 Cream SF, 0.3%
    Intervention: Drug: AN2718
  • Experimental: C
    AN2718 Cream SF, 1%
    Intervention: Drug: AN2718
  • Experimental: D
    AN2718 Gel Vehicle
    Intervention: Other: AN2718
  • Experimental: E
    AN2718 Gel, 1.5%
    Intervention: Drug: AN2718
  • Experimental: F
    AN2718 Gel, 2.5%
    Intervention: Drug: AN2718
  • Experimental: G
    AN2718 Gel, 5%
    Intervention: Drug: AN2718
  • Experimental: H
    AN2718 Gel, 7.5%
    Intervention: Drug: AN2718
  • Active Comparator: I
    Sodium Lauryl Sulfate, 0.5%
    Intervention: Other: Sodium Lauryl Sulfate
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: November 19, 2008)		44
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2008)		36
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion DateNovember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects must meet all of the following criteria for inclusion in the study.

  1. Healthy volunteers of either sex, at least 18 years of age or older.
  2. Females must be of non-childbearing potential (i.e., post-menopausal or surgically sterile [bilateral oophorectomy and/or total hysterectomy]). All females must submit to a urine pregnancy test and have a negative result at Day 1 and at the final study visit.
  3. Subjects may be of any skin type or race providing their degree of skin pigmentation does not interfere with making readings of skin reactions.
  4. Willingness to follow the study procedures and complete the study.
  5. Written informed consent obtained.

Exclusion Criteria:

  1. Any skin disease that would in any way confound interpretation of the study results. Atopic dermatitis/eczema, psoriasis will be excluded.
  2. Chronic asthma will be excluded.
  3. Pregnant or nursing mothers.
  4. A history of sensitivity to any component of any of the formulations.
  5. 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 NCT00781664
Other Study ID Numbers  ICMJE AN2718-TP-101
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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