Topical CP-690,550 For Chronic Plaque Psoriasis
- Registration Number
- NCT00678561
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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
- Evidence of active, latent, or inadequately treated infection with Mycobacterium tuberculosis
- Pregnant or lactating women
- Unwilling to use appropriate contraceptive methods
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.02% CP-690,550 BID CP-690,550 - 0.2% CP-690,550 BID CP-690,550 - 0.02% CP-690,550 QD CP-690,550 - 2% CP-690,550 BID CP-690,550 - 0.2% CP-690,550 QD CP-690,550 - Placebo Vehicle QD Placebo Vehicle - Placebo Vehicle BID Placebo Vehicle - 2% CP-690,550 QD CP-690,550 -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 Baseline, Week 4 TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point severity scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions Week 4 PGA of Psoriasis: The investigator scored each target lesion on a 5-point scale, reflecting the erythema, induration and scaling separately for each target lesions. Each parameter was scored from 0 to 4, with appropriate morphologic descriptors. The 5-point scale for PGA was: 0, "clear"; 1, "almost clear"; 2, "mild"; 3, "moderate"; 4 "severe". The sum of the 3 scores was divided by 3 to obtain a final PGA score. Total score range: 0 to 4, higher score indicated greater severity of disease. Success was considered as PGA response of "clear" and "almost clear".
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 3 Baseline, Week 1, 2, 3 TPSS: all target lesions were scored individually by the investigator for signs of induration, scaling, and erythema. For large target lesions only a portion of the lesion was treated and only the treated portion was rated. Each of the 3 signs was rated on a 5-point scale: 0 = none; 1 = slight; 2 = moderate; 3 = marked; 4 = very marked. Total score range for TPSS was 0 to 12, higher score indicated greater severity of disease.
Number of Participants With Administration Site Adverse Events Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days) An adverse event was any untoward medical occurrence attributed to study drug in a participant who received study drug. Administration site adverse event included documentation of any clinically significant local reaction, such as erosion, vesicles or scabbing.
Drug Plasma Concentrations of CP-690,555 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28 Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Skin Biopsy Drug Concentrations Day 28 Skin biopsy drug concentrations was measured via drug levels in dermis and expressed as nanogram of drug per milligram (mg) of dermis weight. Tissue concentration (ng/mg) = (ng drug/mL extraction solvent multiplied by mL extraction solvent) divided by mg tissue weight; 1 mL of extraction solvent was used.
Trial Locations
- Locations (20)
NewLab Clinical Research Inc.
🇨🇦St. John's, Newfoundland and Labrador, Canada
Central Dermatology, PC
🇺🇸Saint Louis, Missouri, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
K.Papp Clinical Research Inc.
🇨🇦Waterloo, Ontario, Canada
Centre de Recherche Dermatologique du Quebec metropolitain
🇨🇦Quebec, Canada
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Innovaderm Research, Inc.
🇨🇦Montreal, Quebec, Canada
The Imaging Center
🇺🇸High Point, North Carolina, United States
Siena Medical Research
🇨🇦Montreal, Quebec, Canada
Guildford Dermatology Specialists
🇨🇦Surrey, British Columbia, Canada
RUSH University Medical Center
🇺🇸Chicago, Illinois, United States
University of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
University of California Irvine
🇺🇸Irvine, California, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Oregon Medical Research Center, PC
🇺🇸Portland, Oregon, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States