CP-690-550 Ointment For Chronic Plaque Psoriasis

NCT ID: NCT01246583

Last Updated: 2021-01-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-16

Study Completion Date

2011-11-29

Brief Summary

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The study is being conducted to see whether CP-690,550 ointment has potential as a safe and effective treatment for adult patients with mild to moderate chronic plaque psoriasis.

Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Group A

Group Type EXPERIMENTAL

CP-690,550 Ointment 1

Intervention Type DRUG

2% CP-690,550 Ointment 1 twice daily for 4 weeks

Treatment Group B

Group Type PLACEBO_COMPARATOR

Vehicle 1

Intervention Type DRUG

Vehicle 1 twice daily for 4 weeks

Treatment Group C

Group Type EXPERIMENTAL

CP-690,550 Ointment 2

Intervention Type DRUG

2% CP-690,550 Ointment 2 twice daily for 4 weeks

Treatment Group D

Group Type PLACEBO_COMPARATOR

Vehicle 2

Intervention Type DRUG

Vehicle 2 twice daily for 4 weeks

Interventions

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CP-690,550 Ointment 1

2% CP-690,550 Ointment 1 twice daily for 4 weeks

Intervention Type DRUG

Vehicle 1

Vehicle 1 twice daily for 4 weeks

Intervention Type DRUG

CP-690,550 Ointment 2

2% CP-690,550 Ointment 2 twice daily for 4 weeks

Intervention Type DRUG

Vehicle 2

Vehicle 2 twice daily for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months;
* A target plaque of at least 9 sq. cm.

Exclusion Criteria

* Demonstrates "rebound" or "flare" of chronic plaque psoriasis;
* Non plaque form of psoriasis;
* Currently have or history of psoriatic arthritis;
* Current drug induced psoriasis;
* Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months;
* Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Horizon Research Group, Inc.

Mobile, Alabama, United States

Site Status

Dermatology Research Associates

Los Angeles, California, United States

Site Status

Expresscare Medical

Los Angeles, California, United States

Site Status

Park Avenue Dermatology, PA

Orange Park, Florida, United States

Site Status

Skin Specialists, PC

Omaha, Nebraska, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Health Concepts

Rapid City, South Dakota, United States

Site Status

Modern Research Associates, PLLC

Dallas, Texas, United States

Site Status

K.Papp Clinical Research Inc.

Waterloo, Ontario, Canada

Site Status

Innovaderm Research Inc

Montreal, Quebec, Canada

Site Status

Siena Medical Research

Montreal, Quebec, Canada

Site Status

Centre de Recherche Dermatologique du Quebec metropolitain

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Ports WC, Khan S, Lan S, Lamba M, Bolduc C, Bissonnette R, Papp K. A randomized phase 2a efficacy and safety trial of the topical Janus kinase inhibitor tofacitinib in the treatment of chronic plaque psoriasis. Br J Dermatol. 2013 Jul;169(1):137-45. doi: 10.1111/bjd.12266.

Reference Type DERIVED
PMID: 23387374 (View on PubMed)

Related Links

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Other Identifiers

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A3921116

Identifier Type: -

Identifier Source: org_study_id

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