Trial Outcomes & Findings for CP-690-550 Ointment For Chronic Plaque Psoriasis (NCT NCT01246583)

Last Updated: 2021-01-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2021-01-11

Participant Flow

Participant milestones

Participant milestones
Measure	2% CP-690,550 Ointment 1 CP-690,550 2 percent (%) ointment 1, containing a dermal penetration agent, was applied topically to a 300 square centimeter (cm\^2) treatment area twice daily at an application coverage of 3 milligram per cm\^2 (mg/cm\^2) for 4 weeks.	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.	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.	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
Overall Study STARTED	23	13	25	10
Overall Study COMPLETED	22	13	24	9
Overall Study NOT COMPLETED	1	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	2% CP-690,550 Ointment 1 CP-690,550 2 percent (%) ointment 1, containing a dermal penetration agent, was applied topically to a 300 square centimeter (cm\^2) treatment area twice daily at an application coverage of 3 milligram per cm\^2 (mg/cm\^2) for 4 weeks.	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.	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
Overall Study Lost to Follow-up	0	0	1
Overall Study Protocol Violation	0	1	0
Overall Study Withdrawal by Subject	1	0	0

Baseline Characteristics

CP-690-550 Ointment For Chronic Plaque Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	2% CP-690,550 Ointment 2 n=25 Participants 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.	Vehicle 2 n=10 Participants 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	Total n=71 Participants Total of all reporting groups
Age, Customized 18 to 44 years	7 Participants n=93 Participants	5 Participants n=4 Participants	5 Participants n=27 Participants	4 Participants n=483 Participants	21 Participants n=36 Participants
Age, Customized 45 to 64 years	12 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants	6 Participants n=483 Participants	36 Participants n=36 Participants
Age, Customized Greater than or equal to 65 years	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants	0 Participants n=483 Participants	14 Participants n=36 Participants
Sex: Female, Male Female	6 Participants n=93 Participants	8 Participants n=4 Participants	10 Participants n=27 Participants	4 Participants n=483 Participants	28 Participants n=36 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	5 Participants n=4 Participants	15 Participants n=27 Participants	6 Participants n=483 Participants	43 Participants n=36 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=23 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
Percent Change From Baseline in Target Plaque Severity Score (TPSS) at Week 4	-24.26 percent change Standard Deviation 33.43	-53.97 percent change Standard Deviation 29.93	-41.01 percent change Standard Deviation 20.29	-17.24 percent change Standard Deviation 25.40

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=24 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
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 27.50	-46.32 percent change Standard Deviation 29.46	-28.68 percent change Standard Deviation 20.72	-10.32 percent change Standard Deviation 26.53
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	-49.90 percent change Standard Deviation 31.92	-33.12 percent change Standard Deviation 18.92	-27.92 percent change Standard Deviation 19.07
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	-31.00 percent change Standard Deviation 28.54	-25.59 percent change Standard Deviation 18.98	-6.39 percent change Standard Deviation 23.06

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
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	2.52 units on a scale Standard Deviation 0.59	2.62 units on a scale Standard Deviation 0.51	2.50 units on a scale Standard Deviation 0.53
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	-0.53 units on a scale Standard Deviation 0.77	-0.77 units on a scale Standard Deviation 0.73	-0.11 units on a scale Standard Deviation 0.60
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	-0.90 units on a scale Standard Deviation 0.83	-0.83 units on a scale Standard Deviation 0.58	-0.14 units on a scale Standard Deviation 0.69
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	-0.95 units on a scale Standard Deviation 0.90	-1.00 units on a scale Standard Deviation 0.58	-0.75 units on a scale Standard Deviation 0.71
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	-1.14 units on a scale Standard Deviation 0.83	-1.15 units on a scale Standard Deviation 0.69	-0.44 units on a scale Standard Deviation 0.88
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	2.52 units on a scale Standard Deviation 0.67	2.46 units on a scale Standard Deviation 0.52	2.40 units on a scale Standard Deviation 0.52
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	-0.68 units on a scale Standard Deviation 0.82	-0.38 units on a scale Standard Deviation 0.77	0.00 units on a scale Standard Deviation 0.50
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 0.70	-1.05 units on a scale Standard Deviation 0.80	-0.58 units on a scale Standard Deviation 0.79	-0.14 units on a scale Standard Deviation 0.38
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	-1.18 units on a scale Standard Deviation 0.73	-0.69 units on a scale Standard Deviation 0.63	-0.38 units on a scale Standard Deviation 0.74
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 0.90	-1.27 units on a scale Standard Deviation 0.70	-0.92 units on a scale Standard Deviation 0.64	-0.22 units on a scale Standard Deviation 0.67
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	2.17 units on a scale Standard Deviation 0.65	2.23 units on a scale Standard Deviation 0.60	2.30 units on a scale Standard Deviation 0.82
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	-0.95 units on a scale Standard Deviation 0.85	-0.69 units on a scale Standard Deviation 0.48	-0.33 units on a scale Standard Deviation 0.71
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	-1.24 units on a scale Standard Deviation 0.83	-0.75 units on a scale Standard Deviation 0.75	-0.43 units on a scale Standard Deviation 0.79
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	-1.27 units on a scale Standard Deviation 0.88	-0.85 units on a scale Standard Deviation 0.99	-0.75 units on a scale Standard Deviation 0.71
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	-1.32 units on a scale Standard Deviation 0.89	-1.00 units on a scale Standard Deviation 0.91	-0.56 units on a scale Standard Deviation 0.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=24 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
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	42.11 percentage of participants	23.08 percentage of participants	11.11 percentage of participants
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	52.38 percentage of participants	33.33 percentage of participants	28.57 percentage of participants
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	59.09 percentage of participants	23.08 percentage of participants	37.50 percentage of participants
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	63.64 percentage of participants	61.54 percentage of participants	22.22 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=24 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
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	15.79 percentage of participants	0.00 percentage of participants	0.00 percentage of participants
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	28.57 percentage of participants	8.33 percentage of participants	0.00 percentage of participants
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	31.82 percentage of participants	15.38 percentage of participants	0.00 percentage of participants
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	36.36 percentage of participants	23.08 percentage of participants	0.00 percentage of participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=21 Participants 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.	2% CP-690,550 Ointment 1 n=20 Participants 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.	Vehicle 1 n=12 Participants 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.	Vehicle 2 n=8 Participants 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
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	-14.26 percent change Standard Deviation 34.86	-11.26 percent change Standard Deviation 28.55	-3.50 percent change Standard Deviation 7.32
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	-22.67 percent change Standard Deviation 40.18	-8.35 percent change Standard Deviation 37.19	-18.72 percent change Standard Deviation 22.18
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	-36.21 percent change Standard Deviation 42.22	-13.52 percent change Standard Deviation 42.92	-13.59 percent change Standard Deviation 38.56
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	-38.39 percent change Standard Deviation 43.76	-19.61 percent change Standard Deviation 49.93	-4.98 percent change Standard Deviation 27.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Itch Severity Item (ISI) Baseline	4.36 units on a scale Standard Deviation 2.53	4.09 units on a scale Standard Deviation 2.52	5.54 units on a scale Standard Deviation 3.10	6.20 units on a scale Standard Deviation 2.62
Itch Severity Item (ISI) Week 1	3.52 units on a scale Standard Deviation 2.74	2.63 units on a scale Standard Deviation 2.54	4.69 units on a scale Standard Deviation 3.45	4.22 units on a scale Standard Deviation 3.31
Itch Severity Item (ISI) Week 2	3.42 units on a scale Standard Deviation 2.57	2.24 units on a scale Standard Deviation 2.23	3.92 units on a scale Standard Deviation 3.12	4.71 units on a scale Standard Deviation 3.15
Itch Severity Item (ISI) Week 3	2.86 units on a scale Standard Deviation 2.59	2.32 units on a scale Standard Deviation 2.42	3.69 units on a scale Standard Deviation 3.30	3.50 units on a scale Standard Deviation 3.02
Itch Severity Item (ISI) Week 4	2.30 units on a scale Standard Deviation 2.20	1.55 units on a scale Standard Deviation 2.04	3.38 units on a scale Standard Deviation 2.90	4.44 units on a scale Standard Deviation 2.88

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=24 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
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	-1.90 units on a scale Standard Deviation 2.14	-1.83 units on a scale Standard Deviation 3.24	-1.43 units on a scale Standard Deviation 3.87
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	-1.47 units on a scale Standard Deviation 2.04	-0.85 units on a scale Standard Deviation 1.63	-2.00 units on a scale Standard Deviation 3.74
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	-1.86 units on a scale Standard Deviation 1.91	-1.85 units on a scale Standard Deviation 2.79	-2.75 units on a scale Standard Deviation 4.17
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	-2.64 units on a scale Standard Deviation 1.97	-2.15 units on a scale Standard Deviation 2.85	-1.78 units on a scale Standard Deviation 3.87

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Very Dissatisfied	16.0 percentage of participants	9.1 percentage of participants	15.4 percentage of participants	44.4 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Very Satisfied	32.0 percentage of participants	50.0 percentage of participants	23.1 percentage of participants	0.0 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Somewhat Satisfied	20.0 percentage of participants	18.2 percentage of participants	38.5 percentage of participants	11.1 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Slightly Satisfied	12.0 percentage of participants	4.5 percentage of participants	0 percentage of participants	11.1 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Neither Satisfied nor Dissatisfied	4.0 percentage of participants	13.6 percentage of participants	15.4 percentage of participants	11.1 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Slightly Dissatisfied	4.0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants in Each Patient Satisfaction With Study Medication (PSSM) Response Category Somewhat Dissatisfied	12.0 percentage of participants	4.5 percentage of participants	7.7 percentage of participants	22.2 percentage of participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Number of Participants With Administration Site Adverse Events	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: Severe, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: None, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: Mild, Immediate Stinging/Burning	2 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: Moderate, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: Severe, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: None, Persistent Stinging/Burning	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: Mild, Persistent Stinging/Burning	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Baseline: Moderate, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: None, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: None, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: Mild, Immediate Stinging/Burning	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: Moderate, Immediate Stinging/Burning	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: Severe, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: None, Persistent Stinging/Burning	0 Participants	1 Participants	2 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: Mild, Immediate Stinging/Burning	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: Moderate, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: Severe, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: None, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: Mild, Immediate Stinging/Burning	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: Moderate, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: Severe, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: None, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: Mild, Immediate Stinging/Burning	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: Moderate, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: Severe, Immediate Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: Mild, Persistent Stinging/Burning	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: Moderate, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 1: Severe, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: None, Persistent Stinging/Burning	1 Participants	1 Participants	0 Participants	2 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: Mild, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: Moderate, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 2: Severe, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: None, Persistent Stinging/Burning	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: Mild, Persistent Stinging/Burning	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: Moderate, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 3: Severe, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: None, Persistent Stinging/Burning	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: Mild, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: Moderate, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Burning/Stinging of Psoriatic or Perilesional Skin in The Treatment Area Week 4: Severe, Persistent Stinging/Burning	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Baseline, Erythema: Moderate Reaction	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Baseline, Letter Grade: Burning, Stinging, Itching	2 Participants	2 Participants	2 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Baseline,Superficial Observation:Hyperpigmentation	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Baseline,Superficial Observation: Scaling-Flacking	2 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Baseline, Superficial Observation: Glazing	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 1, Erythema: Trace Reaction	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 1, Erythema: Moderate Reaction	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 1, Letter Grade: Burning, Stinging, Itching	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 1, Superficial Observation: Peeling	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 1, Superficial Observation: Scaling-Flacking	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 2, Erythema: Trace Reaction	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 2, Letter Grade: Burning, Stinging, Itching	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 2, Superficial Observation: Scaling-Flacking	1 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 3, Erythema: Trace Reaction	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 3, Letter Grade: Burning, Stinging, Itching	2 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Draize Score of Perilesional Skin in The Treatment Area Week 4, Superficial Observation: Hyperpigmentation	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
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	77.91 mmHg Standard Deviation 9.87	74.81 mmHg Standard Deviation 9.67	76.60 mmHg Standard Deviation 10.86
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	-3.18 mmHg Standard Deviation 7.24	-2.04 mmHg Standard Deviation 7.17	-1.94 mmHg Standard Deviation 7.28
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 9.50	-1.86 mmHg Standard Deviation 7.41	-2.25 mmHg Standard Deviation 5.89	0.29 mmHg Standard Deviation 5.80
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	-2.23 mmHg Standard Deviation 8.09	-3.81 mmHg Standard Deviation 9.04	-2.13 mmHg Standard Deviation 8.70
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	-2.16 mmHg Standard Deviation 7.97	-1.31 mmHg Standard Deviation 6.94	-1.06 mmHg Standard Deviation 6.58
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	120.57 mmHg Standard Deviation 14.83	115.42 mmHg Standard Deviation 12.77	116.05 mmHg Standard Deviation 15.85
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 8.20	-2.29 mmHg Standard Deviation 8.48	3.58 mmHg Standard Deviation 8.76	3.39 mmHg Standard Deviation 7.33
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	-2.24 mmHg Standard Deviation 12.99	0.33 mmHg Standard Deviation 7.24	-3.07 mmHg Standard Deviation 5.99
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	-0.73 mmHg Standard Deviation 12.14	0.65 mmHg Standard Deviation 9.29	-0.81 mmHg Standard Deviation 11.24
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	-0.55 mmHg Standard Deviation 10.42	2.96 mmHg Standard Deviation 9.73	1.06 mmHg Standard Deviation 9.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Change From Baseline in Heart Rate at Week 1, 2, 3, 4 Baseline	66.12 beats per minute Standard Deviation 6.82	67.24 beats per minute Standard Deviation 10.64	66.77 beats per minute Standard Deviation 6.24	73.75 beats per minute Standard Deviation 8.54
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	2.21 beats per minute Standard Deviation 9.29	3.12 beats per minute Standard Deviation 9.98	6.39 beats per minute Standard Deviation 8.66
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	2.95 beats per minute Standard Deviation 10.75	2.71 beats per minute Standard Deviation 6.18	0.36 beats per minute Standard Deviation 4.41
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	0.61 beats per minute Standard Deviation 7.96	2.27 beats per minute Standard Deviation 8.76	2.50 beats per minute Standard Deviation 3.92
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	2.39 beats per minute Standard Deviation 7.73	2.85 beats per minute Standard Deviation 10.60	-2.00 beats per minute Standard Deviation 3.50

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=24 Participants 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.	2% CP-690,550 Ointment 1 n=22 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=9 Participants 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
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Baseline: RR Interval	962.3 milliseconds (msec) Standard Deviation 111.02	984.7 milliseconds (msec) Standard Deviation 165.17	958.4 milliseconds (msec) Standard Deviation 120.78	887.9 milliseconds (msec) Standard Deviation 124.81
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Change at Week 4: RR Interval	-23.1 milliseconds (msec) Standard Deviation 107.99	-47.7 milliseconds (msec) Standard Deviation 80.50	-21.5 milliseconds (msec) Standard Deviation 114.31	-8.8 milliseconds (msec) Standard Deviation 78.53
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Baseline: PR Interval	159.0 milliseconds (msec) Standard Deviation 22.27	165.3 milliseconds (msec) Standard Deviation 19.80	163.8 milliseconds (msec) Standard Deviation 26.10	170.4 milliseconds (msec) Standard Deviation 20.70
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Change at Week 4: PR Interval	1.7 milliseconds (msec) Standard Deviation 16.73	-3.5 milliseconds (msec) Standard Deviation 11.89	2.0 milliseconds (msec) Standard Deviation 10.41	4.2 milliseconds (msec) Standard Deviation 11.90
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Baseline: QRS Complex	95.3 milliseconds (msec) Standard Deviation 8.38	92.8 milliseconds (msec) Standard Deviation 5.94	93.8 milliseconds (msec) Standard Deviation 9.78	93.0 milliseconds (msec) Standard Deviation 5.83
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Change at Week 4: QRS Complex	-1.3 milliseconds (msec) Standard Deviation 7.11	-1.5 milliseconds (msec) Standard Deviation 7.33	-2.8 milliseconds (msec) Standard Deviation 9.11	-0.3 milliseconds (msec) Standard Deviation 9.45
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Baseline: QT Interval	411.1 milliseconds (msec) Standard Deviation 26.46	400.2 milliseconds (msec) Standard Deviation 21.45	400.1 milliseconds (msec) Standard Deviation 26.91	392.3 milliseconds (msec) Standard Deviation 19.02
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Change at Week 4: QT Interval	-8.1 milliseconds (msec) Standard Deviation 27.36	-2.7 milliseconds (msec) Standard Deviation 11.40	-1.2 milliseconds (msec) Standard Deviation 22.42	2.9 milliseconds (msec) Standard Deviation 16.04
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Baseline: QTcF Interval	417.0 milliseconds (msec) Standard Deviation 19.39	404.0 milliseconds (msec) Standard Deviation 17.23	406.5 milliseconds (msec) Standard Deviation 18.16	409.6 milliseconds (msec) Standard Deviation 20.03
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Change at Week 4: QTcF Interval	-4.8 milliseconds (msec) Standard Deviation 19.62	3.6 milliseconds (msec) Standard Deviation 12.88	3.0 milliseconds (msec) Standard Deviation 12.86	4.3 milliseconds (msec) Standard Deviation 14.34
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Baseline: QTcB Interval	420.1 milliseconds (msec) Standard Deviation 19.96	406.3 milliseconds (msec) Standard Deviation 24.59	409.8 milliseconds (msec) Standard Deviation 18.53	418.6 milliseconds (msec) Standard Deviation 26.88
Change From Baseline in Electrocardiogram (ECG) Findings at Week 4 Change at Week 4: QTcB Interval	-2.9 milliseconds (msec) Standard Deviation 19.77	7.1 milliseconds (msec) Standard Deviation 16.83	5.8 milliseconds (msec) Standard Deviation 15.03	5.4 milliseconds (msec) Standard Deviation 16.80

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Change From Baseline in Hemoglobin Level at Week 2, 4 Baseline	14.21 grams per deciliter (g/dL) Standard Deviation 1.26	14.56 grams per deciliter (g/dL) Standard Deviation 1.34	13.68 grams per deciliter (g/dL) Standard Deviation 1.41	13.90 grams per deciliter (g/dL) Standard Deviation 1.29
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	-0.20 grams per deciliter (g/dL) Standard Deviation 0.59	0.12 grams per deciliter (g/dL) Standard Deviation 0.48	-0.06 grams per deciliter (g/dL) Standard Deviation 0.35
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	-0.01 grams per deciliter (g/dL) Standard Deviation 0.56	-0.08 grams per deciliter (g/dL) Standard Deviation 0.66	-0.09 grams per deciliter (g/dL) Standard Deviation 0.39

SECONDARY outcome

Timeframe: Baseline, Week 2, 4

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
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	227.30 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 69.97	212.85 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 58.76	214.90 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 58.67
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	6.38 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 20.88	6.85 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 28.31	13.00 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 15.68
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	1.05 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 13.88	-2.46 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 15.33	2.50 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 12.65
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	3.87 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 1.36	3.75 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 1.06	3.79 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 1.48
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	0.00 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 0.59	0.00 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 0.57	0.23 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 0.51
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	-0.01 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 0.77	-0.21 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 0.41	0.01 10^3 per cubic millimeter (10^3/mm^3) Standard Deviation 0.57

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
Change From Baseline in Creatinine Level at Week 2, 4 Baseline	0.93 milligram per deciliter (mg/dL) Standard Deviation 0.14	1.00 milligram per deciliter (mg/dL) Standard Deviation 0.22	0.89 milligram per deciliter (mg/dL) Standard Deviation 0.19	0.89 milligram per deciliter (mg/dL) Standard Deviation 0.17
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	-0.02 milligram per deciliter (mg/dL) Standard Deviation 0.06	-0.01 milligram per deciliter (mg/dL) Standard Deviation 0.06	-0.04 milligram per deciliter (mg/dL) Standard Deviation 0.09
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	-0.01 milligram per deciliter (mg/dL) Standard Deviation 0.06	-0.01 milligram per deciliter (mg/dL) Standard Deviation 0.07	-0.00 milligram per deciliter (mg/dL) Standard Deviation 0.05

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	2% CP-690,550 Ointment 2 n=25 Participants 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.	2% CP-690,550 Ointment 1 n=23 Participants 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.	Vehicle 1 n=13 Participants 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.	Vehicle 2 n=10 Participants 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
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	4.14 international unit per liter (IU/L) Standard Deviation 49.49	19.62 international unit per liter (IU/L) Standard Deviation 73.16	-6.88 international unit per liter (IU/L) Standard Deviation 22.25
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	-5.76 international unit per liter (IU/L) Standard Deviation 17.67	-3.23 international unit per liter (IU/L) Standard Deviation 5.45	-0.13 international unit per liter (IU/L) Standard Deviation 1.96
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 61.20	117.91 international unit per liter (IU/L) Standard Deviation 67.38	106.62 international unit per liter (IU/L) Standard Deviation 73.11	93.10 international unit per liter (IU/L) Standard Deviation 32.29
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	-1.05 international unit per liter (IU/L) Standard Deviation 40.05	-11.00 international unit per liter (IU/L) Standard Deviation 17.88	8.00 international unit per liter (IU/L) Standard Deviation 56.44
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	24.57 international unit per liter (IU/L) Standard Deviation 12.35	22.77 international unit per liter (IU/L) Standard Deviation 6.69	21.10 international unit per liter (IU/L) Standard Deviation 5.38
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	-2.00 international unit per liter (IU/L) Standard Deviation 7.46	-1.23 international unit per liter (IU/L) Standard Deviation 3.83	-2.00 international unit per liter (IU/L) Standard Deviation 3.57
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	-2.29 international unit per liter (IU/L) Standard Deviation 7.18	-1.08 international unit per liter (IU/L) Standard Deviation 3.09	0.63 international unit per liter (IU/L) Standard Deviation 3.46
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	32.22 international unit per liter (IU/L) Standard Deviation 26.77	28.08 international unit per liter (IU/L) Standard Deviation 16.01	27.60 international unit per liter (IU/L) Standard Deviation 13.37
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	-4.48 international unit per liter (IU/L) Standard Deviation 14.88	-3.54 international unit per liter (IU/L) Standard Deviation 4.77	-0.67 international unit per liter (IU/L) Standard Deviation 7.00

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	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.	2% CP-690,550 Ointment 1 n=20 Participants 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.	Vehicle 1 n=23 Participants 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.	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
Plasma Concentration of CP-690,550 0 hours	—	0.1336 ng/mL Standard Deviation 0.1499	0.0313 ng/mL Standard Deviation 0.0742	—
Plasma Concentration of CP-690,550 1 hour	—	0.1522 ng/mL Standard Deviation 0.1839	0.0434 ng/mL Standard Deviation 0.1083	—
Plasma Concentration of CP-690,550 2 hours	—	0.1548 ng/mL Standard Deviation 0.2089	0.0570 ng/mL Standard Deviation 0.1459	—
Plasma Concentration of CP-690,550 4 hours	—	0.1514 ng/mL Standard Deviation 0.2244	0.0553 ng/mL Standard Deviation 0.1420	—

Adverse Events

2% CP-690,550 Ointment 1

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Vehicle 1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

2% CP-690,550 Ointment 2

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Vehicle 2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER

Other adverse events
Measure	2% CP-690,550 Ointment 1 n=23 participants at risk 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.	Vehicle 1 n=13 participants at risk 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.	2% CP-690,550 Ointment 2 n=25 participants at risk 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.	Vehicle 2 n=10 participants at risk 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
Gastrointestinal disorders Dyspepsia	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Mouth ulceration	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Application site erythema	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Eye infection viral	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Labyrinthitis	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Laryngitis	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.0% 2/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pharyngitis	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tonsillitis	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Tooth abscess	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection staphylococcal	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Laceration	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Wound dehiscence	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Electrocardiogram T wave inversion	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Torticollis	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Nerve compression	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Presyncope	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 1/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Penis disorder	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	4.3% 1/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/23 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/13 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.0% 1/25 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.