Topical CP-690,550 For Chronic Plaque Psoriasis

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NCT00678561

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Study Location
University of California Irvine
Irvine, California, 92697, United States
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Contact
1-800-718-1021
[email protected]
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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
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Having chronic plaque psoriasis for at least 6 months

- Able to withdraw all prior psoriasis treatments

- Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

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


- Evidence of active, latent, or inadequately treated infection with Mycobacterium
tuberculosis


- Pregnant or lactating women


- Unwilling to use appropriate contraceptive methods

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Advanced Information
Descriptive Information
Brief Title  ICMJE Topical CP-690,550 For Chronic Plaque Psoriasis
Official Title  ICMJE PHASE 2A RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, INTRA-INDIVIDUAL COMPARISON TRIAL ASSESSING SAFETY, TOLERATION, PHARMACOKINETICS AND PILOT EFFICACY OF 4 WEEKS TREATMENT WITH TOPICAL CP-690,550 IN CHRONIC PLAQUE PSORIASIS
Brief Summary Study will test effectiveness of an experimental drug applied once or twice daily to two psoriasis plaques. Requires 1 clinic visit each week for 5 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: CP-690,550
    Topical treatment once daily for 28 days
  • Drug: CP-690,550
    Topical treatment twice daily for 28 days
  • Drug: Placebo Vehicle
    Topical treatment once daily for 28 days
  • Drug: Placebo Vehicle
    Topical treatment twice daily for 28 days
Study Arms  ICMJE
  • Experimental: 2% CP-690,550 QD
    Intervention: Drug: CP-690,550
  • Experimental: 0.2% CP-690,550 QD
    Intervention: Drug: CP-690,550
  • Experimental: 0.02% CP-690,550 QD
    Intervention: Drug: CP-690,550
  • Experimental: 2% CP-690,550 BID
    Intervention: Drug: CP-690,550
  • Experimental: 0.2% CP-690,550 BID
    Intervention: Drug: CP-690,550
  • Experimental: 0.02% CP-690,550 BID
    Intervention: Drug: CP-690,550
  • Placebo Comparator: Placebo Vehicle QD
    Intervention: Drug: Placebo Vehicle
  • Placebo Comparator: Placebo Vehicle BID
    Intervention: Drug: Placebo Vehicle
Publications * Ports WC, Feldman SR, Gupta P, Tan H, Johnson TR, Bissonnette R. Randomized Pilot Clinical Trial of Tofacitinib Solution for Plaque Psoriasis: Challenges of the Intra-Subject Study Design. J Drugs Dermatol. 2015 Aug;14(8):777-84.

*   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: August 14, 2009)		81
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2008)		98
Actual Study Completion Date  ICMJE July 24, 2009
Actual Primary Completion Date July 9, 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Having chronic plaque psoriasis for at least 6 months
  • Able to withdraw all prior psoriasis treatments
  • Must agree to avoid prolonged exposure to the sun and avoid use of tanning booths or other ultraviolet light sources during the study

Exclusion Criteria:

  • Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
  • Pregnant or lactating women
  • Unwilling to use appropriate contraceptive methods
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00678561
Other Study ID Numbers  ICMJE A3921038
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2020

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