AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis

NCT01300052

Last updated date
Study Location
The Savin Center
New Haven, Connecticut, 06511, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriasis
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

- Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals

- Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits

- Women of childbearing potential must agree to use contraception for the entire study period

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


- Any dermatological conditions that could interfere with clinical evaluations


- Concurrent or recent use of certain topical or systemic medications without a
sufficient washout period


- Significant confounding conditions as assessed by study doctor


- Participated in any other trial of an investigational drug within 30 days or
participation in a research study concurrent with this study


- Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)


- Use of a beta-blocking medication (e.g., propranolol) if the dose has not been
stabilized for at least 3 months


- Pregnancy or lactation

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Advanced Information
Descriptive Information
Brief Title  ICMJE AN2728 Topical Ointment to Treat Mild-to-Moderate Plaque-Type Psoriasis
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, 12-Week Study Of The Safety And Efficacy Of AN2728 Versus AN2728 Vehicle In The Treatment Of Patients With Mild-To-Moderate Plaque-Type Psoriasis
Brief Summary The purpose of this study is to determine whether AN2728 topical ointment is a safe and effective treatment for mild-to-moderate plaque-type psoriasis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: AN2728 ointment, 2%
    AN2728 ointment, 2%, applied twice daily for 12 weeks
  • Drug: Ointment Vehicle
    Ointment Vehicle, applied twice daily for 12 weeks
Study Arms  ICMJE
  • Experimental: AN2728 ointment, 2%
    AN2728 ointment, 2%
    Intervention: Drug: AN2728 ointment, 2%
  • Placebo Comparator: Ointment Vehicle
    Ointment Vehicle
    Intervention: Drug: Ointment Vehicle
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: October 20, 2011)
68
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2011)
60
Actual Study Completion Date  ICMJE June 6, 2011
Actual Primary Completion Date June 6, 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of stable mild-to-moderate plaque-type psoriasis involving 2-35% of total body surface area (BSA) excluding face, scalp, and genitals
  • Willingness and ability to apply study medication as directed, comply with study instructions, and commit to attending all study visits
  • Women of childbearing potential must agree to use contraception for the entire study period

Exclusion Criteria:

  • Any dermatological conditions that could interfere with clinical evaluations
  • Concurrent or recent use of certain topical or systemic medications without a sufficient washout period
  • Significant confounding conditions as assessed by study doctor
  • Participated in any other trial of an investigational drug within 30 days or participation in a research study concurrent with this study
  • Use of lithium- or hydroxychloroquine-containing products (e.g., Plaquenil)
  • Use of a beta-blocking medication (e.g., propranolol) if the dose has not been stabilized for at least 3 months
  • Pregnancy or lactation
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT01300052
Other Study ID Numbers  ICMJE AN2728-PSR-204
C3291017 ( 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 Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2017

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