Clinical trial NCT00678561: Topical CP-690,550 For Chronic Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Keywords: chronic plaque psoriasis
topical treatment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-15
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions
timeFrame: Week 4
measure: Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3
timeFrame: Baseline, Week 1, 2, 3
measure: Number of Participants With Administration Site Adverse Events
timeFrame: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
measure: Drug Plasma Concentrations of CP-690,555
timeFrame: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
measure: Skin Biopsy Drug Concentrations
timeFrame: Day 28
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Chicago
country: United States
facility: RUSH University Medical Center
state: Illinois
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Saint Louis
country: United States
facility: Central Dermatology, PC
state: Missouri
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: High Point
country: United States
facility: The Imaging Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah School of Medicine
state: Utah
city: Surrey
country: Canada
facility: Guildford Dermatology Specialists
state: British Columbia
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc.
state: Newfoundland and Labrador
city: Waterloo
country: Canada
facility: K.Papp Clinical Research Inc.
state: Ontario
city: Montreal
country: Canada
facility: Innovaderm Research, Inc.
state: Quebec
city: Montreal
country: Canada
facility: Siena Medical Research
state: Quebec
city: Quebec
country: Canada
facility: Centre de Recherche Dermatologique du Quebec metropolitain
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.