Psoriasis
Conditions
Keywords
Multi Site, Randomized, Placebo Controlled, Double Blind, Parallel Group, chronic plaque psoriasis, topical treatment, skin diseases, papulosquamous
Brief summary
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.
Interventions
DRUGCP-690,550 Ointment 1
2% CP-690,550 Ointment 1 twice daily for 4 weeks
DRUGVehicle 1
Vehicle 1 twice daily for 4 weeks
DRUGCP-690,550 Ointment 2
2% CP-690,550 Ointment 2 twice daily for 4 weeks
DRUGVehicle 2
Vehicle 2 twice daily for 4 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Mild to moderate chronic plaque psoriasis (psoriasis vulgaris), with the duration of at least 6 months; * A target plaque of at least 9 sq. cm.
Exclusion criteria
* Demonstrates rebound or flare of chronic plaque psoriasis; * Non plaque form of psoriasis; * Currently have or history of psoriatic arthritis; * Current drug induced psoriasis; * Currently on systemic therapy or was on systemic therapy for psoriasis within the previous 6 months; * Currently on phototherapy for psoriasis or was on phototherapy within the previous 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline, Weeks 1, 2, 3, 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. |
| Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 1, 2, 3, 4 | 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. |
| Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 1, 2, 3, 4 | 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. |
| Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Baseline, Week 1, 2, 3, 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. |
| Itch Severity Item (ISI) | Baseline, Week 1, 2, 3, 4 | 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. |
| Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Baseline, Week 1, 2, 3, 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. |
| Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Week 4 | 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. |
| Number of Participants With Administration Site Adverse Events | Baseline up to follow up visit (Day 36-39 after last dose of study treatment) (up to maximum of 9.5 weeks) | 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. |
| Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline, Week 1, 2, 3, 4 | 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). |
| Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Baseline, Weeks 1, 2, 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. |
| Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline, 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. |
| Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Baseline, 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. |
| Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline, 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. |
| Change From Baseline in Hemoglobin Level at Week 2, 4 | Baseline, Week 2, 4 | — |
| Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline, Week 2, 4 | — |
| Change From Baseline in Creatinine Level at Week 2, 4 | Baseline, Week 2, 4 | — |
| Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline, Week 2, 4 | — |
| Plasma Concentration of CP-690,550 | 0 (predose), 1, 2 and 4-9 hours postdose on Day 29 or early termination | 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. |
| Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Week 1, 2, 3, 4 | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2% CP-690,550 Ointment 1 CP-690,550 2% ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm\^2 treatment area twice daily at an application coverage of 3 mg/cm\^2 for 4 weeks. | 23 |
| Vehicle 1 Placebo ointment (Vehicle 1), matched to 2% CP-690,550 ointment 1, containing a dermal penetration agent, was applied topically to a 300 cm\^2 treatment area twice daily at an application coverage of 3 mg/cm\^2 for 4 weeks. | 13 |
| 2% CP-690,550 Ointment 2 CP-690,550 2% ointment 2, without a dermal penetration agent, was applied topically to a 300 cm\^2 treatment area twice daily at an application coverage of 3 mg/cm\^2 for 4 weeks. | 25 |
| Vehicle 2 Placebo ointment (Vehicle 2), matched to 2% CP-690,550 ointment 2, without a dermal penetration agent, was applied topically to a 300 cm\^2 treatment area twice daily at an application coverage of 3 mg/cm\^2 for 4 weeks | 10 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 2% CP-690,550 Ointment 1 | Vehicle 1 | 2% CP-690,550 Ointment 2 | Vehicle 2 | Total |
|---|---|---|---|---|---|
| Age, Customized 18 to 44 years | 7 Participants | 5 Participants | 5 Participants | 4 Participants | 21 Participants |
| Age, Customized 45 to 64 years | 12 Participants | 5 Participants | 13 Participants | 6 Participants | 36 Participants |
| Age, Customized Greater than or equal to 65 years | 4 Participants | 3 Participants | 7 Participants | 0 Participants | 14 Participants |
| Sex: Female, Male Female | 6 Participants | 8 Participants | 10 Participants | 4 Participants | 28 Participants |
| Sex: Female, Male Male | 17 Participants | 5 Participants | 15 Participants | 6 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 23 | 3 / 13 | 9 / 25 | 3 / 10 |
| serious Total, serious adverse events | 0 / 23 | 0 / 13 | 0 / 25 | 0 / 10 |
Outcome results
Primary
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
Population: Full analysis set (FAS) included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here Overall Number of Participants Analyzed signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -53.97 percent change | Standard Deviation 29.93 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -41.01 percent change | Standard Deviation 20.29 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -24.26 percent change | Standard Deviation 33.43 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4 | -17.24 percent change | Standard Deviation 25.4 |
Secondary
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
Population: FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: ALT | -4.48 international unit per liter (IU/L) | Standard Deviation 14.88 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: AST | -2.00 international unit per liter (IU/L) | Standard Deviation 7.46 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: ALT | -5.76 international unit per liter (IU/L) | Standard Deviation 17.67 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: CK | 117.91 international unit per liter (IU/L) | Standard Deviation 67.38 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: CK | 4.14 international unit per liter (IU/L) | Standard Deviation 49.49 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: AST | -2.29 international unit per liter (IU/L) | Standard Deviation 7.18 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: AST | 24.57 international unit per liter (IU/L) | Standard Deviation 12.35 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: ALT | 32.22 international unit per liter (IU/L) | Standard Deviation 26.77 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: CK | -1.05 international unit per liter (IU/L) | Standard Deviation 40.05 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: ALT | 28.08 international unit per liter (IU/L) | Standard Deviation 16.01 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: AST | -1.08 international unit per liter (IU/L) | Standard Deviation 3.09 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: CK | 106.62 international unit per liter (IU/L) | Standard Deviation 73.11 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: CK | 19.62 international unit per liter (IU/L) | Standard Deviation 73.16 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: ALT | -3.23 international unit per liter (IU/L) | Standard Deviation 5.45 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: AST | -1.23 international unit per liter (IU/L) | Standard Deviation 3.83 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: CK | -11.00 international unit per liter (IU/L) | Standard Deviation 17.88 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: AST | 22.77 international unit per liter (IU/L) | Standard Deviation 6.69 |
| Vehicle 1 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: ALT | -3.54 international unit per liter (IU/L) | Standard Deviation 4.77 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: CK | -2.13 international unit per liter (IU/L) | Standard Deviation 25.91 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: AST | 23.04 international unit per liter (IU/L) | Standard Deviation 14.04 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: AST | 1.84 international unit per liter (IU/L) | Standard Deviation 4.59 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: AST | 0.70 international unit per liter (IU/L) | Standard Deviation 5.98 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: ALT | 24.28 international unit per liter (IU/L) | Standard Deviation 17.81 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: ALT | 2.12 international unit per liter (IU/L) | Standard Deviation 4.75 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: ALT | 0.61 international unit per liter (IU/L) | Standard Deviation 5.75 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: CK | 100.16 international unit per liter (IU/L) | Standard Deviation 61.2 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: CK | 13.00 international unit per liter (IU/L) | Standard Deviation 47.55 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: AST | 21.10 international unit per liter (IU/L) | Standard Deviation 5.38 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: CK | 93.10 international unit per liter (IU/L) | Standard Deviation 32.29 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Baseline: ALT | 27.60 international unit per liter (IU/L) | Standard Deviation 13.37 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: AST | 0.63 international unit per liter (IU/L) | Standard Deviation 3.46 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: CK | -6.88 international unit per liter (IU/L) | Standard Deviation 22.25 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: CK | 8.00 international unit per liter (IU/L) | Standard Deviation 56.44 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: AST | -2.00 international unit per liter (IU/L) | Standard Deviation 3.57 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 4: ALT | -0.13 international unit per liter (IU/L) | Standard Deviation 1.96 |
| Vehicle 2 | Change From Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Creatine Kinase (CK) Level at Week 2, 4 | Change at Week 2: ALT | -0.67 international unit per liter (IU/L) | Standard Deviation 7 |
Secondary
Change From Baseline in Creatinine Level at Week 2, 4
Time frame: Baseline, Week 2, 4
Population: FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Creatinine Level at Week 2, 4 | Baseline | 1.00 milligram per deciliter (mg/dL) | Standard Deviation 0.22 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 4 | -0.01 milligram per deciliter (mg/dL) | Standard Deviation 0.06 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 2 | -0.02 milligram per deciliter (mg/dL) | Standard Deviation 0.06 |
| Vehicle 1 | Change From Baseline in Creatinine Level at Week 2, 4 | Baseline | 0.89 milligram per deciliter (mg/dL) | Standard Deviation 0.19 |
| Vehicle 1 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 4 | -0.01 milligram per deciliter (mg/dL) | Standard Deviation 0.07 |
| Vehicle 1 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 2 | -0.01 milligram per deciliter (mg/dL) | Standard Deviation 0.06 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 2 | 0.03 milligram per deciliter (mg/dL) | Standard Deviation 0.07 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Creatinine Level at Week 2, 4 | Baseline | 0.93 milligram per deciliter (mg/dL) | Standard Deviation 0.14 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 4 | -0.02 milligram per deciliter (mg/dL) | Standard Deviation 0.07 |
| Vehicle 2 | Change From Baseline in Creatinine Level at Week 2, 4 | Baseline | 0.89 milligram per deciliter (mg/dL) | Standard Deviation 0.17 |
| Vehicle 2 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 4 | -0.00 milligram per deciliter (mg/dL) | Standard Deviation 0.05 |
| Vehicle 2 | Change From Baseline in Creatinine Level at Week 2, 4 | Change at Week 2 | -0.04 milligram per deciliter (mg/dL) | Standard Deviation 0.09 |
Secondary
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
Population: Safety analysis set included all participants who received at least one dose of the investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcB Interval | 7.1 milliseconds (msec) | Standard Deviation 16.83 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcF Interval | 3.6 milliseconds (msec) | Standard Deviation 12.88 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QT Interval | -2.7 milliseconds (msec) | Standard Deviation 11.4 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: RR Interval | 984.7 milliseconds (msec) | Standard Deviation 165.17 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcB Interval | 406.3 milliseconds (msec) | Standard Deviation 24.59 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: PR Interval | 165.3 milliseconds (msec) | Standard Deviation 19.8 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: PR Interval | -3.5 milliseconds (msec) | Standard Deviation 11.89 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: RR Interval | -47.7 milliseconds (msec) | Standard Deviation 80.5 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcF Interval | 404.0 milliseconds (msec) | Standard Deviation 17.23 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QRS Complex | 92.8 milliseconds (msec) | Standard Deviation 5.94 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QRS Complex | -1.5 milliseconds (msec) | Standard Deviation 7.33 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QT Interval | 400.2 milliseconds (msec) | Standard Deviation 21.45 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: RR Interval | -21.5 milliseconds (msec) | Standard Deviation 114.31 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QT Interval | 400.1 milliseconds (msec) | Standard Deviation 26.91 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: PR Interval | 2.0 milliseconds (msec) | Standard Deviation 10.41 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcB Interval | 409.8 milliseconds (msec) | Standard Deviation 18.53 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcB Interval | 5.8 milliseconds (msec) | Standard Deviation 15.03 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QT Interval | -1.2 milliseconds (msec) | Standard Deviation 22.42 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: RR Interval | 958.4 milliseconds (msec) | Standard Deviation 120.78 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QRS Complex | -2.8 milliseconds (msec) | Standard Deviation 9.11 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QRS Complex | 93.8 milliseconds (msec) | Standard Deviation 9.78 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: PR Interval | 163.8 milliseconds (msec) | Standard Deviation 26.1 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcF Interval | 3.0 milliseconds (msec) | Standard Deviation 12.86 |
| Vehicle 1 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcF Interval | 406.5 milliseconds (msec) | Standard Deviation 18.16 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QT Interval | -8.1 milliseconds (msec) | Standard Deviation 27.36 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: RR Interval | 962.3 milliseconds (msec) | Standard Deviation 111.02 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: RR Interval | -23.1 milliseconds (msec) | Standard Deviation 107.99 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: PR Interval | 159.0 milliseconds (msec) | Standard Deviation 22.27 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: PR Interval | 1.7 milliseconds (msec) | Standard Deviation 16.73 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QRS Complex | 95.3 milliseconds (msec) | Standard Deviation 8.38 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QRS Complex | -1.3 milliseconds (msec) | Standard Deviation 7.11 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QT Interval | 411.1 milliseconds (msec) | Standard Deviation 26.46 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcB Interval | 420.1 milliseconds (msec) | Standard Deviation 19.96 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcB Interval | -2.9 milliseconds (msec) | Standard Deviation 19.77 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcF Interval | 417.0 milliseconds (msec) | Standard Deviation 19.39 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcF Interval | -4.8 milliseconds (msec) | Standard Deviation 19.62 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QRS Complex | -0.3 milliseconds (msec) | Standard Deviation 9.45 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QRS Complex | 93.0 milliseconds (msec) | Standard Deviation 5.83 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: RR Interval | 887.9 milliseconds (msec) | Standard Deviation 124.81 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcB Interval | 5.4 milliseconds (msec) | Standard Deviation 16.8 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: PR Interval | 4.2 milliseconds (msec) | Standard Deviation 11.9 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: PR Interval | 170.4 milliseconds (msec) | Standard Deviation 20.7 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QTcF Interval | 4.3 milliseconds (msec) | Standard Deviation 14.34 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcF Interval | 409.6 milliseconds (msec) | Standard Deviation 20.03 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: QT Interval | 2.9 milliseconds (msec) | Standard Deviation 16.04 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QT Interval | 392.3 milliseconds (msec) | Standard Deviation 19.02 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Change at Week 4: RR Interval | -8.8 milliseconds (msec) | Standard Deviation 78.53 |
| Vehicle 2 | Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 | Baseline: QTcB Interval | 418.6 milliseconds (msec) | Standard Deviation 26.88 |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 3 | 0.61 beats per minute | Standard Deviation 7.96 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 1 | 2.21 beats per minute | Standard Deviation 9.29 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 4 | 2.39 beats per minute | Standard Deviation 7.73 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 2 | 2.95 beats per minute | Standard Deviation 10.75 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Baseline | 67.24 beats per minute | Standard Deviation 10.64 |
| Vehicle 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 2 | 2.71 beats per minute | Standard Deviation 6.18 |
| Vehicle 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 3 | 2.27 beats per minute | Standard Deviation 8.76 |
| Vehicle 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 4 | 2.85 beats per minute | Standard Deviation 10.6 |
| Vehicle 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 1 | 3.12 beats per minute | Standard Deviation 9.98 |
| Vehicle 1 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Baseline | 66.77 beats per minute | Standard Deviation 6.24 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 2 | 2.04 beats per minute | Standard Deviation 7.91 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Baseline | 66.12 beats per minute | Standard Deviation 6.82 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 1 | 2.28 beats per minute | Standard Deviation 8.31 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 3 | 4.45 beats per minute | Standard Deviation 12.41 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 4 | 0.63 beats per minute | Standard Deviation 7.08 |
| Vehicle 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 3 | 2.50 beats per minute | Standard Deviation 3.92 |
| Vehicle 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 1 | 6.39 beats per minute | Standard Deviation 8.66 |
| Vehicle 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Baseline | 73.75 beats per minute | Standard Deviation 8.54 |
| Vehicle 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 2 | 0.36 beats per minute | Standard Deviation 4.41 |
| Vehicle 2 | Change From Baseline in Heart Rate at Week 1, 2, 3, 4 | Change at Week 4 | -2.00 beats per minute | Standard Deviation 3.5 |
Secondary
Change From Baseline in Hemoglobin Level at Week 2, 4
Time frame: Baseline, Week 2, 4
Population: FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed =participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Baseline | 14.56 grams per deciliter (g/dL) | Standard Deviation 1.34 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 4 | -0.01 grams per deciliter (g/dL) | Standard Deviation 0.56 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 2 | -0.20 grams per deciliter (g/dL) | Standard Deviation 0.59 |
| Vehicle 1 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Baseline | 13.68 grams per deciliter (g/dL) | Standard Deviation 1.41 |
| Vehicle 1 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 4 | -0.08 grams per deciliter (g/dL) | Standard Deviation 0.66 |
| Vehicle 1 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 2 | 0.12 grams per deciliter (g/dL) | Standard Deviation 0.48 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 2 | 0.19 grams per deciliter (g/dL) | Standard Deviation 0.52 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Baseline | 14.21 grams per deciliter (g/dL) | Standard Deviation 1.26 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 4 | -0.02 grams per deciliter (g/dL) | Standard Deviation 0.49 |
| Vehicle 2 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Baseline | 13.90 grams per deciliter (g/dL) | Standard Deviation 1.29 |
| Vehicle 2 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 4 | -0.09 grams per deciliter (g/dL) | Standard Deviation 0.39 |
| Vehicle 2 | Change From Baseline in Hemoglobin Level at Week 2, 4 | Change at Week 2 | -0.06 grams per deciliter (g/dL) | Standard Deviation 0.35 |
Secondary
Change From Baseline in Platelet and Neutrophil Count at Week 2, 4
Time frame: Baseline, Week 2, 4
Population: FAS population included all participants who were randomized to the study and received at least one dose of the randomized investigational drug (CP-690,550 or vehicle). Number Analyzed =participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Platelet | 227.30 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 69.97 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Platelet | 6.38 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 20.88 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Platelet | 1.05 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 13.88 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Neutrophil | 3.87 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 1.36 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Neutrophil | 0.00 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.59 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Neutrophil | -0.01 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.77 |
| Vehicle 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Neutrophil | -0.21 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.41 |
| Vehicle 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Neutrophil | 3.75 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 1.06 |
| Vehicle 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Platelet | 212.85 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 58.76 |
| Vehicle 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Platelet | -2.46 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 15.33 |
| Vehicle 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Platelet | 6.85 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 28.31 |
| Vehicle 1 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Neutrophil | 0.00 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.57 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Platelet | 0.00 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 21.37 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Platelet | -7.30 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 23.07 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Neutrophil | 4.71 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 1.04 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Neutrophil | -0.34 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.94 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Neutrophil | 0.06 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.88 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Platelet | 233.68 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 50.79 |
| Vehicle 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Neutrophil | 0.23 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.51 |
| Vehicle 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Neutrophil | 0.01 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 0.57 |
| Vehicle 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 2: Platelet | 13.00 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 15.68 |
| Vehicle 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Neutrophil | 3.79 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 1.48 |
| Vehicle 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Baseline: Platelet | 214.90 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 58.67 |
| Vehicle 2 | Change From Baseline in Platelet and Neutrophil Count at Week 2, 4 | Change at Week 4: Platelet | 2.50 10^3 per cubic millimeter (10^3/mm^3) | Standard Deviation 12.65 |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=number of participants evaluable for this measure at specified time points for each treatment groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Systolic BP | 120.57 mmHg | Standard Deviation 14.83 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Systolic BP | -2.29 mmHg | Standard Deviation 8.48 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Systolic BP | -0.73 mmHg | Standard Deviation 12.14 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Systolic BP | -2.24 mmHg | Standard Deviation 12.99 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Diastolic BP | -2.23 mmHg | Standard Deviation 8.09 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Diastolic BP | 77.91 mmHg | Standard Deviation 9.87 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Diastolic BP | -1.86 mmHg | Standard Deviation 7.41 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Diastolic BP | -2.16 mmHg | Standard Deviation 7.97 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Systolic BP | -0.55 mmHg | Standard Deviation 10.42 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Diastolic BP | -3.18 mmHg | Standard Deviation 7.24 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Systolic BP | 0.65 mmHg | Standard Deviation 9.29 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Systolic BP | 115.42 mmHg | Standard Deviation 12.77 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Systolic BP | 2.96 mmHg | Standard Deviation 9.73 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Diastolic BP | -2.04 mmHg | Standard Deviation 7.17 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Diastolic BP | 74.81 mmHg | Standard Deviation 9.67 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Systolic BP | 3.58 mmHg | Standard Deviation 8.76 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Diastolic BP | -1.31 mmHg | Standard Deviation 6.94 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Diastolic BP | -2.25 mmHg | Standard Deviation 5.89 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Diastolic BP | -3.81 mmHg | Standard Deviation 9.04 |
| Vehicle 1 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Systolic BP | 0.33 mmHg | Standard Deviation 7.24 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Diastolic BP | 75.52 mmHg | Standard Deviation 8.63 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Systolic BP | 0.67 mmHg | Standard Deviation 8.62 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Systolic BP | -5.07 mmHg | Standard Deviation 9.04 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Diastolic BP | -3.63 mmHg | Standard Deviation 9.5 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Diastolic BP | -0.26 mmHg | Standard Deviation 8.64 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Systolic BP | -3.67 mmHg | Standard Deviation 8.96 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Diastolic BP | -2.61 mmHg | Standard Deviation 7.28 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Systolic BP | 125.62 mmHg | Standard Deviation 16.26 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Systolic BP | -2.85 mmHg | Standard Deviation 8.2 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Diastolic BP | -2.54 mmHg | Standard Deviation 8.32 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Systolic BP | 1.06 mmHg | Standard Deviation 9.33 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Diastolic BP | -1.94 mmHg | Standard Deviation 7.28 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Diastolic BP | 0.29 mmHg | Standard Deviation 5.8 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Diastolic BP | -2.13 mmHg | Standard Deviation 8.7 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 4: Diastolic BP | -1.06 mmHg | Standard Deviation 6.58 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Systolic BP | 116.05 mmHg | Standard Deviation 15.85 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 1: Systolic BP | 3.39 mmHg | Standard Deviation 7.33 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 2: Systolic BP | -3.07 mmHg | Standard Deviation 5.99 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Change at Week 3: Systolic BP | -0.81 mmHg | Standard Deviation 11.24 |
| Vehicle 2 | Change From Baseline in Systolic and Diastolic Blood Pressure at Week 1, 2, 3, 4 | Baseline: Diastolic BP | 76.60 mmHg | Standard Deviation 10.86 |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Scaling | -1.32 units on a scale | Standard Deviation 0.89 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Induration | -1.05 units on a scale | Standard Deviation 0.8 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Induration | -0.68 units on a scale | Standard Deviation 0.82 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Erythema | -1.14 units on a scale | Standard Deviation 0.83 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Scaling | -1.27 units on a scale | Standard Deviation 0.88 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Induration | 2.52 units on a scale | Standard Deviation 0.67 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Erythema | -0.53 units on a scale | Standard Deviation 0.77 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Scaling | -1.24 units on a scale | Standard Deviation 0.83 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Scaling | -0.95 units on a scale | Standard Deviation 0.85 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Scaling | 2.17 units on a scale | Standard Deviation 0.65 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Erythema | -0.90 units on a scale | Standard Deviation 0.83 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Erythema | 2.52 units on a scale | Standard Deviation 0.59 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Induration | -1.27 units on a scale | Standard Deviation 0.7 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Induration | -1.18 units on a scale | Standard Deviation 0.73 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Erythema | -0.95 units on a scale | Standard Deviation 0.9 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Erythema | -0.77 units on a scale | Standard Deviation 0.73 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Scaling | -1.00 units on a scale | Standard Deviation 0.91 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Erythema | 2.62 units on a scale | Standard Deviation 0.51 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Erythema | -0.83 units on a scale | Standard Deviation 0.58 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Erythema | -1.00 units on a scale | Standard Deviation 0.58 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Erythema | -1.15 units on a scale | Standard Deviation 0.69 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Induration | 2.46 units on a scale | Standard Deviation 0.52 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Induration | -0.38 units on a scale | Standard Deviation 0.77 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Induration | -0.58 units on a scale | Standard Deviation 0.79 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Induration | -0.69 units on a scale | Standard Deviation 0.63 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Induration | -0.92 units on a scale | Standard Deviation 0.64 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Scaling | 2.23 units on a scale | Standard Deviation 0.6 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Scaling | -0.69 units on a scale | Standard Deviation 0.48 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Scaling | -0.75 units on a scale | Standard Deviation 0.75 |
| Vehicle 1 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Scaling | -0.85 units on a scale | Standard Deviation 0.99 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Erythema | -0.57 units on a scale | Standard Deviation 0.87 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Induration | -0.33 units on a scale | Standard Deviation 0.7 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Induration | -0.57 units on a scale | Standard Deviation 0.81 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Erythema | -0.42 units on a scale | Standard Deviation 0.72 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Scaling | -0.67 units on a scale | Standard Deviation 1.02 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Induration | -0.43 units on a scale | Standard Deviation 0.9 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Scaling | 2.08 units on a scale | Standard Deviation 0.49 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Erythema | -0.26 units on a scale | Standard Deviation 0.62 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Erythema | 2.44 units on a scale | Standard Deviation 0.51 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Scaling | -0.48 units on a scale | Standard Deviation 0.95 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Scaling | -0.61 units on a scale | Standard Deviation 1.03 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Erythema | -0.61 units on a scale | Standard Deviation 0.89 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Scaling | -0.38 units on a scale | Standard Deviation 0.77 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Induration | 2.28 units on a scale | Standard Deviation 0.46 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Induration | -0.17 units on a scale | Standard Deviation 0.58 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Erythema | -0.75 units on a scale | Standard Deviation 0.71 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Erythema | 2.50 units on a scale | Standard Deviation 0.53 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Scaling | -0.43 units on a scale | Standard Deviation 0.79 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Induration | -0.14 units on a scale | Standard Deviation 0.38 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 2: Erythema | -0.14 units on a scale | Standard Deviation 0.69 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Scaling | -0.56 units on a scale | Standard Deviation 0.88 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Induration | 0.00 units on a scale | Standard Deviation 0.5 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Induration | -0.38 units on a scale | Standard Deviation 0.74 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Scaling | -0.33 units on a scale | Standard Deviation 0.71 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Induration | -0.22 units on a scale | Standard Deviation 0.67 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Induration | 2.40 units on a scale | Standard Deviation 0.52 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 1: Erythema | -0.11 units on a scale | Standard Deviation 0.6 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 3: Scaling | -0.75 units on a scale | Standard Deviation 0.71 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Change at Week 4: Erythema | -0.44 units on a scale | Standard Deviation 0.88 |
| Vehicle 2 | Change From Baseline in Target Plaque Severity Score (TPSS) of Erythema, Induration and Scaling at Weeks 1, 2, 3 and 4 | Baseline: Scaling | 2.30 units on a scale | Standard Deviation 0.82 |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed=participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 1 | -1.47 units on a scale | Standard Deviation 2.04 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 2 | -1.90 units on a scale | Standard Deviation 2.14 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 3 | -1.86 units on a scale | Standard Deviation 1.91 |
| 2% CP-690,550 Ointment 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 4 | -2.64 units on a scale | Standard Deviation 1.97 |
| Vehicle 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 2 | -1.83 units on a scale | Standard Deviation 3.24 |
| Vehicle 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 3 | -1.85 units on a scale | Standard Deviation 2.79 |
| Vehicle 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 4 | -2.15 units on a scale | Standard Deviation 2.85 |
| Vehicle 1 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 1 | -0.85 units on a scale | Standard Deviation 1.63 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 3 | -1.62 units on a scale | Standard Deviation 2.65 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 2 | -1.00 units on a scale | Standard Deviation 2.38 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 4 | -2.13 units on a scale | Standard Deviation 2.65 |
| 2% CP-690,550 Ointment 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 1 | -0.74 units on a scale | Standard Deviation 2.22 |
| Vehicle 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 4 | -1.78 units on a scale | Standard Deviation 3.87 |
| Vehicle 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 2 | -1.43 units on a scale | Standard Deviation 3.87 |
| Vehicle 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 1 | -2.00 units on a scale | Standard Deviation 3.74 |
| Vehicle 2 | Change From Baseline in the Treatment Area Itch Severity Item (ISI) at Week 1, 2, 3 and 4 | Change at Week 3 | -2.75 units on a scale | Standard Deviation 4.17 |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Itch Severity Item (ISI) | Week 3 | 2.32 units on a scale | Standard Deviation 2.42 |
| 2% CP-690,550 Ointment 1 | Itch Severity Item (ISI) | Week 1 | 2.63 units on a scale | Standard Deviation 2.54 |
| 2% CP-690,550 Ointment 1 | Itch Severity Item (ISI) | Week 4 | 1.55 units on a scale | Standard Deviation 2.04 |
| 2% CP-690,550 Ointment 1 | Itch Severity Item (ISI) | Week 2 | 2.24 units on a scale | Standard Deviation 2.23 |
| 2% CP-690,550 Ointment 1 | Itch Severity Item (ISI) | Baseline | 4.09 units on a scale | Standard Deviation 2.52 |
| Vehicle 1 | Itch Severity Item (ISI) | Week 2 | 3.92 units on a scale | Standard Deviation 3.12 |
| Vehicle 1 | Itch Severity Item (ISI) | Week 3 | 3.69 units on a scale | Standard Deviation 3.3 |
| Vehicle 1 | Itch Severity Item (ISI) | Week 4 | 3.38 units on a scale | Standard Deviation 2.9 |
| Vehicle 1 | Itch Severity Item (ISI) | Week 1 | 4.69 units on a scale | Standard Deviation 3.45 |
| Vehicle 1 | Itch Severity Item (ISI) | Baseline | 5.54 units on a scale | Standard Deviation 3.1 |
| 2% CP-690,550 Ointment 2 | Itch Severity Item (ISI) | Week 2 | 3.42 units on a scale | Standard Deviation 2.57 |
| 2% CP-690,550 Ointment 2 | Itch Severity Item (ISI) | Baseline | 4.36 units on a scale | Standard Deviation 2.53 |
| 2% CP-690,550 Ointment 2 | Itch Severity Item (ISI) | Week 1 | 3.52 units on a scale | Standard Deviation 2.74 |
| 2% CP-690,550 Ointment 2 | Itch Severity Item (ISI) | Week 3 | 2.86 units on a scale | Standard Deviation 2.59 |
| 2% CP-690,550 Ointment 2 | Itch Severity Item (ISI) | Week 4 | 2.30 units on a scale | Standard Deviation 2.2 |
| Vehicle 2 | Itch Severity Item (ISI) | Week 3 | 3.50 units on a scale | Standard Deviation 3.02 |
| Vehicle 2 | Itch Severity Item (ISI) | Week 1 | 4.22 units on a scale | Standard Deviation 3.31 |
| Vehicle 2 | Itch Severity Item (ISI) | Baseline | 6.20 units on a scale | Standard Deviation 2.62 |
| Vehicle 2 | Itch Severity Item (ISI) | Week 2 | 4.71 units on a scale | Standard Deviation 3.15 |
| Vehicle 2 | Itch Severity Item (ISI) | Week 4 | 4.44 units on a scale | Standard Deviation 2.88 |
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. 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)
Population: Safety analysis set included all participants who received at least one dose of the investigational drug (CP-690,550 or vehicle).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 2% CP-690,550 Ointment 1 | Number of Participants With Administration Site Adverse Events | 1 Participants |
| Vehicle 1 | Number of Participants With Administration Site Adverse Events | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Administration Site Adverse Events | 0 Participants |
| Vehicle 2 | Number of Participants With Administration Site Adverse Events | 0 Participants |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Immediate Stinging/Burning | 1 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Persistent Stinging/Burning | 1 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Persistent Stinging/Burning | 2 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Immediate Stinging/Burning | 2 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 1 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Immediate Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Immediate Stinging/Burning | 2 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Persistent Stinging/Burning | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Persistent Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Immediate Stinging/Burning | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Immediate Stinging/Burning | 1 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Immediate Stinging/Burning | 1 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Persistent Stinging/Burning | 1 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Moderate, Immediate Stinging/Burning | 1 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Moderate, Persistent Stinging/Burning | 1 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 3: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Baseline: Mild, Persistent Stinging/Burning | 1 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Severe, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 1: Mild, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: None, Persistent Stinging/Burning | 2 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: None, Immediate Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 4: Moderate, Persistent Stinging/Burning | 0 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Immediate Stinging/Burning | 2 Participants |
| Vehicle 2 | Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area | Week 2: Mild, Persistent Stinging/Burning | 0 Participants |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Superficial Observation: Glazing | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Letter Grade: Burning, Stinging, Itching | 2 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation:Hyperpigmentation | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation: Scaling-Flacking | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Erythema: Moderate Reaction | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Trace Reaction | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Moderate Reaction | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Letter Grade: Burning, Stinging, Itching | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Peeling | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Scaling-Flacking | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Erythema: Trace Reaction | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Superficial Observation: Scaling-Flacking | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Erythema: Trace Reaction | 1 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| 2% CP-690,550 Ointment 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 4, Superficial Observation: Hyperpigmentation | 1 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Trace Reaction | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Peeling | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 4, Superficial Observation: Hyperpigmentation | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Letter Grade: Burning, Stinging, Itching | 1 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Scaling-Flacking | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation:Hyperpigmentation | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Erythema: Trace Reaction | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Superficial Observation: Glazing | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Moderate Reaction | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation: Scaling-Flacking | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Letter Grade: Burning, Stinging, Itching | 2 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Superficial Observation: Scaling-Flacking | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Erythema: Trace Reaction | 0 Participants |
| Vehicle 1 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Erythema: Moderate Reaction | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Trace Reaction | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Superficial Observation: Glazing | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Erythema: Trace Reaction | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Moderate Reaction | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 4, Superficial Observation: Hyperpigmentation | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Peeling | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Scaling-Flacking | 2 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Letter Grade: Burning, Stinging, Itching | 2 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Erythema: Trace Reaction | 2 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Erythema: Moderate Reaction | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Letter Grade: Burning, Stinging, Itching | 2 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Superficial Observation: Scaling-Flacking | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation:Hyperpigmentation | 1 Participants |
| 2% CP-690,550 Ointment 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation: Scaling-Flacking | 2 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 4, Superficial Observation: Hyperpigmentation | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation:Hyperpigmentation | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Erythema: Moderate Reaction | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Erythema: Trace Reaction | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Moderate Reaction | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Superficial Observation: Scaling-Flacking | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline, Superficial Observation: Glazing | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Scaling-Flacking | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Erythema: Trace Reaction | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Erythema: Trace Reaction | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 3, Letter Grade: Burning, Stinging, Itching | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 1, Superficial Observation: Peeling | 0 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Baseline,Superficial Observation: Scaling-Flacking | 1 Participants |
| Vehicle 2 | Number of Participants With Draize Score of Perilesional Skin in The Treatment Area | Week 2, Letter Grade: Burning, Stinging, Itching | 0 Participants |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 1 | 15.79 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 2 | 28.57 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 3 | 31.82 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 4 | 36.36 percentage of participants |
| Vehicle 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 2 | 8.33 percentage of participants |
| Vehicle 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 3 | 15.38 percentage of participants |
| Vehicle 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 4 | 23.08 percentage of participants |
| Vehicle 1 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 1 | 0.00 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 3 | 9.52 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 2 | 0.00 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 4 | 17.39 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 1 | 0.00 percentage of participants |
| Vehicle 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 4 | 0.00 percentage of participants |
| Vehicle 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 2 | 0.00 percentage of participants |
| Vehicle 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 1 | 0.00 percentage of participants |
| Vehicle 2 | Percentage of Participants Achieving Decrease From Baseline of Greater Than or Equal to 2 Points in Treatment Area Overall Severity of Psoriasis Score | Week 3 | 0.00 percentage of participants |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed signifies number of participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Dissatisfied | 0 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Neither Satisfied nor Dissatisfied | 13.6 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Satisfied | 4.5 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Dissatisfied | 9.1 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Dissatisfied | 4.5 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Satisfied | 18.2 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Satisfied | 50.0 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Dissatisfied | 15.4 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Satisfied | 23.1 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Satisfied | 38.5 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Satisfied | 0 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Neither Satisfied nor Dissatisfied | 15.4 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Dissatisfied | 0 percentage of participants |
| Vehicle 1 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Dissatisfied | 7.7 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Satisfied | 20.0 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Dissatisfied | 16.0 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Dissatisfied | 12.0 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Dissatisfied | 4.0 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Satisfied | 12.0 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Neither Satisfied nor Dissatisfied | 4.0 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Satisfied | 32.0 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Satisfied | 11.1 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Neither Satisfied nor Dissatisfied | 11.1 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Dissatisfied | 0 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Satisfied | 0.0 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Very Dissatisfied | 44.4 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Somewhat Dissatisfied | 22.2 percentage of participants |
| Vehicle 2 | Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category | Slightly Satisfied | 11.1 percentage of participants |
Secondary
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.
Time frame: Week 1, 2, 3, 4
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 1 | 42.11 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 2 | 52.38 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 3 | 59.09 percentage of participants |
| 2% CP-690,550 Ointment 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 4 | 63.64 percentage of participants |
| Vehicle 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 2 | 33.33 percentage of participants |
| Vehicle 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 3 | 23.08 percentage of participants |
| Vehicle 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 4 | 61.54 percentage of participants |
| Vehicle 1 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 1 | 23.08 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 3 | 38.10 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 2 | 29.17 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 4 | 39.13 percentage of participants |
| 2% CP-690,550 Ointment 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 1 | 21.74 percentage of participants |
| Vehicle 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 4 | 22.22 percentage of participants |
| Vehicle 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 2 | 28.57 percentage of participants |
| Vehicle 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 1 | 11.11 percentage of participants |
| Vehicle 2 | Percentage of Participants With Treatment Area Overall Severity of Psoriasis Response of Clear (0) or Almost Clear (1) | Week 3 | 37.50 percentage of participants |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here, Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 1 | -14.26 percent change | Standard Deviation 34.86 |
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 2 | -22.67 percent change | Standard Deviation 40.18 |
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 3 | -36.21 percent change | Standard Deviation 42.22 |
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 4 | -38.39 percent change | Standard Deviation 43.76 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 2 | -8.35 percent change | Standard Deviation 37.19 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 3 | -13.52 percent change | Standard Deviation 42.92 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 4 | -19.61 percent change | Standard Deviation 49.93 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 1 | -11.26 percent change | Standard Deviation 28.55 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 3 | -4.90 percent change | Standard Deviation 30.23 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 2 | -5.52 percent change | Standard Deviation 22.82 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 4 | -8.71 percent change | Standard Deviation 31.23 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 1 | -3.72 percent change | Standard Deviation 19.18 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 4 | -4.98 percent change | Standard Deviation 27.05 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 2 | -18.72 percent change | Standard Deviation 22.18 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 1 | -3.50 percent change | Standard Deviation 7.32 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Area at Week 1, 2, 3 and 4 | Change at Week 3 | -13.59 percent change | Standard Deviation 38.56 |
Secondary
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
Population: FAS included all participants who were randomized to study and received at least 1 dose of investigational drug (CP-690,550 or vehicle). Here Overall Number of Participants Analyzed= participants who were evaluable for this measure. Number Analyzed=participants evaluable for this measure at specified time points for each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 1 | -31.00 percent change | Standard Deviation 28.54 |
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 3 | -49.90 percent change | Standard Deviation 31.92 |
| 2% CP-690,550 Ointment 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 2 | -46.32 percent change | Standard Deviation 29.46 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 1 | -25.59 percent change | Standard Deviation 18.98 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 3 | -33.12 percent change | Standard Deviation 18.92 |
| Vehicle 1 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 2 | -28.68 percent change | Standard Deviation 20.72 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 2 | -17.26 percent change | Standard Deviation 27.5 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 1 | -12.65 percent change | Standard Deviation 22.19 |
| 2% CP-690,550 Ointment 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 3 | -26.32 percent change | Standard Deviation 32.48 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 1 | -6.39 percent change | Standard Deviation 23.06 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 3 | -27.92 percent change | Standard Deviation 19.07 |
| Vehicle 2 | Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Weeks 1, 2 and 3 | Change at Week 2 | -10.32 percent change | Standard Deviation 26.53 |
Secondary
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
Population: Pharmacokinetic analysis set included all treated participants who had at least one plasma concentration value above the lower limit of quantification.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 2% CP-690,550 Ointment 1 | Plasma Concentration of CP-690,550 | 0 hours | 0.1336 ng/mL | Standard Deviation 0.1499 |
| 2% CP-690,550 Ointment 1 | Plasma Concentration of CP-690,550 | 1 hour | 0.1522 ng/mL | Standard Deviation 0.1839 |
| 2% CP-690,550 Ointment 1 | Plasma Concentration of CP-690,550 | 2 hours | 0.1548 ng/mL | Standard Deviation 0.2089 |
| 2% CP-690,550 Ointment 1 | Plasma Concentration of CP-690,550 | 4 hours | 0.1514 ng/mL | Standard Deviation 0.2244 |
| Vehicle 1 | Plasma Concentration of CP-690,550 | 4 hours | 0.0553 ng/mL | Standard Deviation 0.142 |
| Vehicle 1 | Plasma Concentration of CP-690,550 | 0 hours | 0.0313 ng/mL | Standard Deviation 0.0742 |
| Vehicle 1 | Plasma Concentration of CP-690,550 | 2 hours | 0.0570 ng/mL | Standard Deviation 0.1459 |
| Vehicle 1 | Plasma Concentration of CP-690,550 | 1 hour | 0.0434 ng/mL | Standard Deviation 0.1083 |