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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
2% CP-690,550 Ointment 1 twice daily for 4 weeks
Vehicle 1 twice daily for 4 weeks
2% CP-690,550 Ointment 2 twice daily for 4 weeks
Horizon Research Group, Inc.
Mobile, Alabama, United States
Dermatology Research Associates
Los Angeles, California, United States
Expresscare Medical
Los Angeles, California, United States
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4
Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis.
Time frame: Baseline, Week 4
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3
Target plaque was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The individual signs severity sub scores were summed to calculate TPSS. The total score varied in increments of 1 and ranged from 1 to 12, with higher scores representing greater severity of psoriasis.
Time frame: Baseline, Weeks 1, 2, 3
Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4
Target plaque severity was evaluated individually for signs of induration, scaling and erythema. Each of the 3 signs was rated on 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked.
Time frame: Baseline, Weeks 1, 2, 3, 4
Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of "Clear" (0) or "Almost Clear" (1)
Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score range: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
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Vehicle 2 twice daily for 4 weeks
Park Avenue Dermatology, PA
Orange Park, Florida, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Health Concepts
Rapid City, South Dakota, United States
Modern Research Associates, PLLC
Dallas, Texas, United States
K.Papp Clinical Research Inc.
Waterloo, Ontario, Canada
Innovaderm Research Inc
Montreal, Quebec, Canada
...and 2 more locations
Time frame: Week 1, 2, 3, 4
Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score
Treatment area overall severity of psoriasis is global consideration of the erythema, induration and scaling across all psoriatic lesions, rated separately over the treatment area according to a 5-point severity scale ranged from 0 to 4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. The severity scores are summed and averaged after which the total average is rounded to the nearest whole number score to determine the treatment area overall severity of psoriasis score and category. Total possible score: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.
Time frame: Week 1, 2, 3, 4
Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4
A tracing of the target plaque on transparent film was used to quantify the target plaque area. The target plaque area was calculated by image analysis (planimetry). At baseline, target plaque area was determined prior to randomization to confirm the target plaque size of at least 9 cm\^2.
Time frame: Baseline, Week 1, 2, 3, 4
Itch Severity Item (ISI)
The severity of itch was assessed using a single-item Patient Reported Outcome (PRO). Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching.
Time frame: Baseline, Week 1, 2, 3, 4
Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4
The severity of itch was assessed using a single-item PRO. Participants were asked to assess their worst itching due to psoriasis at the treatment area over the past 24 hours on a numeric rating scale ranging from of 0-10 where, 0=no itching and 10=worst possible itching.
Time frame: Baseline, Week 1, 2, 3, 4
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category
The PSSM evaluates overall participants satisfaction with the study treatment. Participants response evaluation was based on single 7-point item: 1=very satisfied, 2=somewhat satisfied, 3=slightly satisfied, 4=neither satisfied nor dissatisfied, 5=slightly dissatisfied, 6=somewhat dissatisfied, and 7=very dissatisfied.
Time frame: Week 4
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. Application site adverse event included documentation of any clinically significant local reaction, e.g erosion, vesicles or scabbing.
Time frame: Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks)
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area
Burning/stinging symptoms at the treatment area including target plaque, additional plaque/s within the treatment area (if any) and treated perilesional skin (if any) were queried from the participants and scored by the investigator using a 4-point scale: 0=none; 1=Mild; 2=Moderate; 3=Severe. Except at baseline pre-dosing, burning/stinging was assessed for 2 time periods based on the maximum burning or stinging that the participant has experienced: Immediate (within 5 minutes after application); Persistent (beyond 5 minutes after application).
Time frame: Baseline, Week 1, 2, 3, 4
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area
Draize scoring evaluated perilesional skin within treatment area for erythema and presence/absence of other signs and symptoms. Erythema score ranged from 0 to 4 as: 0(no reaction visible), 1(trace reactions- barely perceptible pinkness), 2(mild reaction- readily visible pinkness), 3(moderate reaction- definite redness), 4 (Strong to severe reaction- very intense redness). Letter grade defined as: J(Burning, stinging, itching), E(Edema), P(Papules), V(Vesicles), B(Bulla reaction), S(Spreading), W(Weeping), I(Induration), XC(Additional comments). Superficial observations defined as: G(Glazing), Y(Peeling), C(Scab), D(Hyperpigmentation), H(Hypopigmentation), F(Fissuring), R(Erosion), U(Ulceration), K(Scaling). Erythema and other signs/symptoms with at least 1 participant with Draize Score of Perilesional Skin in the treatment area were reported in this outcome measure.
Time frame: Baseline, Week 1, 2, 3, 4
Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4
Blood pressure (BP) was measured in duplicate (approximately 5 minutes apart) using a standard calibrated BP measuring device. BP defined as pressure exerted by circulating blood upon walls of blood vessels. Diastolic BP is minimum pressure in arteries, near beginning of cardiac cycle when ventricles are filled with blood. Systolic BP is peak pressure in arteries, near end of the cardiac cycle when ventricles are contracting. Normal blood pressure is less than 120 millimeters of mercury (mmHg) systolic and less than 80 mmHg diastolic. Change=value at week 1, 2, 3, 4 minus value at baseline.
Time frame: Baseline, Week 1, 2, 3, 4
Change From Baseline in Heart Rate at Week 1, 2, 3, 4
Heart (pulse) rate was measured in duplicate (approximately 5 minutes apart) for a minimum of 30 seconds. Heart rate is the number of heartbeats per unit of time, usually per minute. The heart rate is based on the number of contractions of the ventricles (the lower chambers of the heart). Change=value at week 1, 2, 3, 4 minus value at baseline.
Time frame: Baseline, Week 1, 2, 3, 4
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4
A single standard supine 12-lead Electrocardiogram (ECG) was performed after the participant had rested quietly for at least 10 minutes. ECG parameters included RR interval, PR interval, QRS complex, QT interval, QTcB (corrected for heart rate using Bazett's formula) interval, and QTcF (corrected for heart rate using Fridericia's formula) interval.
Time frame: Baseline, Week 4
Change From Baseline in Hemoglobin Level at Week 2, 4
Time frame: Baseline, Week 2, 4
Change From Baseline in Platelet and Neutrophil Count at Week 2, 4
Time frame: Baseline, Week 2, 4
Change From Baseline in Creatinine Level at Week 2, 4
Time frame: Baseline, Week 2, 4
Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4
Time frame: Baseline, Week 2, 4
Plasma Concentration of CP-690,550
Summary statistics were calculated by setting concentration values below the lower limit of quantification (lower limit of quantification=0.1 nanogram per milliliter \[ng/mL\]) to zero. Summary statistics were not presented if number of observations above lower limit of quantification (NALQ) = 0.
Time frame: 0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination