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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
81
Topical treatment once daily for 28 days
Topical treatment once daily for 28 days
Topical treatment once daily for 28 days
University of California Irvine
Irvine, California, United States
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.
Time frame: Baseline, Week 4
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".
Time frame: Week 4
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.
Time frame: Baseline, Week 1, 2, 3
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.
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Topical treatment twice daily for 28 days
Topical treatment twice daily for 28 days
Topical treatment twice daily for 28 days
Topical treatment once daily for 28 days
Topical treatment twice daily for 28 days
Therapeutics Clinical Research
San Diego, California, United States
RUSH University Medical Center
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Central Dermatology, PC
St Louis, Missouri, United States
Dermatology Consulting Services
High Point, North Carolina, United States
The Imaging Center
High Point, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
...and 10 more locations
Time frame: Baseline up to 7 to 10 days after last dose of study treatment (maximum up to 38 days)
Drug Plasma Concentrations of CP-690,555
Concentrations below the limit of quantification (LOQ) were not estimable. The LOQ was 0.1 ng/mL.
Time frame: 0 hour (pre-dose) on Day 14 and 0 hour (pre-dose), 1, 2, 9 hours post-dose on Day 28
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.
Time frame: Day 28