Topical CP-690,550 For Chronic Plaque Psoriasis

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678561
• Other study ID #: A3921038
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2008
• Est. completion date: July 24, 2009

Study information

• Verified date: December 2020
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: July 24, 2009
• Est. primary completion date: July 9, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Drug:
• CP-690,550
Topical treatment once daily for 28 days
• CP-690,550
Topical treatment once daily for 28 days
• CP-690,550
Topical treatment once daily for 28 days
• CP-690,550
Topical treatment twice daily for 28 days
• CP-690,550
Topical treatment twice daily for 28 days
• CP-690,550
Topical treatment twice daily for 28 days
• Placebo Vehicle
Topical treatment once daily for 28 days
• Placebo Vehicle
Topical treatment twice daily for 28 days

Locations

Country	Name	City	State
Canada	Innovaderm Research, Inc.	Montreal	Quebec
Canada	Siena Medical Research	Montreal	Quebec
Canada	Centre de Recherche Dermatologique du Quebec metropolitain	Quebec
Canada	NewLab Clinical Research Inc.	St. John's	Newfoundland and Labrador
Canada	Guildford Dermatology Specialists	Surrey	British Columbia
Canada	K.Papp Clinical Research Inc.	Waterloo	Ontario
United States	University of Michigan	Ann Arbor	Michigan
United States	DermResearch, Inc.	Austin	Texas
United States	Tufts Medical Center	Boston	Massachusetts
United States	RUSH University Medical Center	Chicago	Illinois
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	The Imaging Center	High Point	North Carolina
United States	University of California Irvine	Irvine	California
United States	Oregon Health & Science University	Portland	Oregon
United States	Oregon Medical Research Center, PC	Portland	Oregon
United States	Central Dermatology, PC	Saint Louis	Missouri
United States	University of Utah School of Medicine	Salt Lake City	Utah
United States	Therapeutics Clinical Research	San Diego	California
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change From Baseline in Target Plaque Severity Score (TPSS) at 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.	Baseline, Week 4
Secondary	Percentage of Participants With Success Based on Physician's Global Assessment (PGA) of Target Lesions	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".	Week 4
Secondary	Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 1, 2 and 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.	Baseline, Week 1, 2, 3
Secondary	Number of Participants With Administration Site Adverse Events	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.	Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Secondary	Drug Plasma Concentrations of CP-690,555	Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.	0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
Secondary	Skin Biopsy Drug Concentrations	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.	Day 28

External Links

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