Psoriasis Vulgaris
Conditions
Keywords
psoriasis, plaque, vulgaris, phase 1, randomized, double-blind, topical, safety
Brief summary
This is a vehicle and comparator controlled Proof of Mechanism (PoM) trial to evaluate the effect on psoriasis disease activity and safety of topically applied PF 06263276 in subjects with psoriasis vulgaris.
Interventions
DRUGPF06263276
4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
OTHERVehicle
Active ingredient-free vehicle to 4% solution
DRUG2%Tofacitinib Ointment
Daily Dosage: approximately 4 mg tofacitinib
DRUGDaivonex
Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
DRUGDaivonex Ointment
Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Healthy male and/or female subjects age 18 years and older, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG or clinical laboratory tests. * Subjects with psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas. * The target lesion(s) should be on the trunk or extremities (excluding palms/soles). Psoriatic lesions on the knees or elbows are not to be used as a target lesion.
Exclusion criteria
* Subjects with psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis. * Treatment with any systemic medications which in the opinion of the investigator might counter or influence the trial aim (including anti psoriasis medications, eg, corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (eg, beta blocker, anti malarial drugs, lithium) or phototherapy/psoralen+UVA (PUVA) within 4 weeks preceding the treatment phase of the trial and during the trial. * Treatment with any locally acting medications (including anti-psoriasis medications like vitamin D analogues, dithranol) within 4 weeks of the treatment phase.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Day 1 (Baseline), Day 12 | Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 | Day 1 (Baseline), Day 12 | — |
| Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Day 1 (Baseline), Day 8 | — |
| Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | Day 1 (baseline) up to Day 12 | The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported. |
| Global Clinical Assessment at Day 1, 8 and 12 | Day 1, Day 8, Day 12 | Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged \[no effect\]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged). |
| Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 | Day 1 (Baseline), Day 12 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Potentially Clinically Significant Vital Signs Findings | Baseline up to Day 12 | Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) \>=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP \<90 mmHg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mmHg. |
| Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | Baseline up to Day 12 | The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (e.g., urine human chorionic gonadotropin \[hCG\] for females of childbearing potential). |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Baseline up to 28 days after last study drug administration (Day 21) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported. |
Countries
Germany
Participant flow
Pre-assignment details
This trial enrolled participants with chronic plaque type psoriasis and with a treatment area sufficient for 6 treatment fields on 1 to 3 comparable plaques defined as having treatment fields with psoriatic skin thickness/Echo-Poor Band (EPB) of at least 200 micrometers.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 8.8 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
Psoriatic skin thickness was measured using a 20 megahertz (MHz) high frequency sonograph. Serial A-scans were composed and presented on a monitor as a section of the skin.
Time frame: Day 1 (Baseline), Day 12
Population: The Intent-to-Treat (ITT) population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Baseline | 358.9 micrometers | Standard Deviation 132.84 |
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Change at Day 12 | 17.7 micrometers | Standard Deviation 91.1 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Baseline | 353.1 micrometers | Standard Deviation 121.03 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 | Change at Day 12 | 32.9 micrometers | Standard Deviation 96.72 |
p-value: 0.346595% CI: [80.43, 107.99]Mixed Models Analysis
Secondary
Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB
The AUC of psoriatic skin thickness/EPB from Day 1 to Day 12 was determined using the linear trapezoidal rule. The mean raw values are reported.
Time frame: Day 1 (baseline) up to Day 12
Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06263276 4% Solution | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | 4082.60 micrometers*day | Standard Deviation 1726.167 |
| PF-06263276 Vehicle | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | 4161.40 micrometers*day | Standard Deviation 1436.733 |
| Tofacitinib 2% Ointment | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | 3271.93 micrometers*day | Standard Deviation 1210.138 |
| Tofacitinib Vehicle | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | 4013.07 micrometers*day | Standard Deviation 1465.339 |
| Daivonex Solution | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | 3322.40 micrometers*day | Standard Deviation 1663.668 |
| Daivonex Ointment | Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB | 3165.47 micrometers*day | Standard Deviation 1113.937 |
p-value: 0.752995% CI: [74, 124.64]Mixed Models Analysis
p-value: 0.131895% CI: [92.96, 169.75]Mixed Models Analysis
p-value: 0.800995% CI: [79.3, 134.68]Mixed Models Analysis
p-value: 0.101295% CI: [62.94, 104.47]Mixed Models Analysis
Secondary
Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8
Time frame: Day 1 (Baseline), Day 8
Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Baseline | 358.9 micrometers | Standard Deviation 132.84 |
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Change at Day 8 | 18.0 micrometers | Standard Deviation 86.37 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Baseline | 353.1 micrometers | Standard Deviation 121.03 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Change at Day 8 | 38.5 micrometers | Standard Deviation 65.45 |
| Tofacitinib 2% Ointment | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Baseline | 364.1 micrometers | Standard Deviation 135.82 |
| Tofacitinib 2% Ointment | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Change at Day 8 | -90.5 micrometers | Standard Deviation 84.11 |
| Tofacitinib Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Change at Day 8 | 15.1 micrometers | Standard Deviation 104.55 |
| Tofacitinib Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Baseline | 357.3 micrometers | Standard Deviation 135.6 |
| Daivonex Solution | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Change at Day 8 | -98.8 micrometers | Standard Deviation 127.18 |
| Daivonex Solution | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Baseline | 376.1 micrometers | Standard Deviation 148.44 |
| Daivonex Ointment | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Baseline | 364.1 micrometers | Standard Deviation 124.35 |
| Daivonex Ointment | Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 | Change at Day 8 | -104.7 micrometers | Standard Deviation 65.83 |
p-value: 0.334995% CI: [80.3, 107.81]Mixed Models Analysis
p-value: <0.000195% CI: [129.04, 173.34]Mixed Models Analysis
p-value: 0.399195% CI: [91.92, 123.41]Mixed Models Analysis
p-value: <0.000195% CI: [62.08, 83.36]Mixed Models Analysis
Secondary
Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12
Time frame: Day 1 (Baseline), Day 12
Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 | 17.7 micrometers | Standard Deviation 91.1 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12 | -135.5 micrometers | Standard Deviation 114.27 |
p-value: <0.000195% CI: [143.12, 192.25]Mixed Models Analysis
Secondary
Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12
Time frame: Day 1 (Baseline), Day 12
Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 | Baseline | 364.1 micrometers | Standard Deviation 135.82 |
| PF-06263276 4% Solution | Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 | Change at Day 12 | -117.8 micrometers | Standard Deviation 115.15 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 | Baseline | 357.3 micrometers | Standard Deviation 135.6 |
| PF-06263276 Vehicle | Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12 | Change at Day 12 | 0.1 micrometers | Standard Deviation 95.04 |
p-value: <0.000195% CI: [56.46, 75.81]Mixed Models Analysis
Secondary
Global Clinical Assessment at Day 1, 8 and 12
Global Clinical Assessment of the test fields was performed by visual examination using a 5-point score (-1=worsened; 0=unchanged \[no effect\]; 1=slight improvement; 2=clear improvement but not completely healed; 3=completely healed). Clinically apparent differences in erythema and infiltration will contribute to this global assessment. At baseline (Day 1), the score was documented as 0 (unchanged).
Time frame: Day 1, Day 8, Day 12
Population: The ITT population included all participants who had investigational products dispensed and had at least 1 post-baseline assessment of the primary efficacy variable.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 2 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 3 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 0 | 15 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 2 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score -1 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 2 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 0 | 13 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 1 | 2 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score -1 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score -1 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 0 | 13 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 3 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 1 | 2 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 1 | 0 participants |
| PF-06263276 4% Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 3 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 1 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 2 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 0 | 15 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 1 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 0 | 15 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score -1 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 3 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 3 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 0 | 15 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 2 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 1 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 2 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score -1 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score -1 | 0 participants |
| PF-06263276 Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 3 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 0 | 4 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 2 | 3 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 0 | 15 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 0 | 4 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score -1 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 3 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 1 | 8 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 2 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score -1 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 1 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 2 | 3 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 3 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 1 | 8 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score -1 | 0 participants |
| Tofacitinib 2% Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 3 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 1 | 3 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 1 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 3 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 3 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 2 | 1 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 0 | 15 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 0 | 14 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score -1 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 1 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 2 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score -1 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 3 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score -1 | 0 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 0 | 11 participants |
| Tofacitinib Vehicle | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 2 | 1 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 3 | 0 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 2 | 4 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score -1 | 1 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 0 | 1 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 1 | 9 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 2 | 7 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 3 | 0 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 1 | 6 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 3 | 0 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 0 | 15 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 1 | 0 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 2 | 0 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 0 | 1 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score -1 | 0 participants |
| Daivonex Solution | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score -1 | 1 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 0 | 1 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 2 | 0 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 3 | 0 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score -1 | 0 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 2 | 8 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 2 | 8 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score -1 | 1 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 1 | 6 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 0 | 2 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 3 | 0 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 0 | 15 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 12: Score 1 | 4 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score 1 | 0 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 1: Score -1 | 0 participants |
| Daivonex Ointment | Global Clinical Assessment at Day 1, 8 and 12 | Day 8: Score 3 | 0 participants |
Other Pre-specified
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (e.g., urine human chorionic gonadotropin \[hCG\] for females of childbearing potential).
Time frame: Baseline up to Day 12
Population: The safety population included all enrolled participants who received at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06263276 4% Solution | Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern | 6 participants |
Other Pre-specified
Number of Participants With Potentially Clinically Significant Vital Signs Findings
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm), standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) \>=30 millimeters of mercury (mmHg) change from baseline in same posture or SBP \<90 mmHg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mmHg.
Time frame: Baseline up to Day 12
Population: The safety population included all enrolled participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263276 4% Solution | Number of Participants With Potentially Clinically Significant Vital Signs Findings | DBP <50 mmHg | 0 participants |
| PF-06263276 4% Solution | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Pulse Rate <40 or >120 bpm | 0 participants |
| PF-06263276 4% Solution | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Maximum Increase from Baseline in SBP >=30 mmHg | 0 participants |
| PF-06263276 4% Solution | Number of Participants With Potentially Clinically Significant Vital Signs Findings | SBP <90 mmHg | 0 participants |
| PF-06263276 4% Solution | Number of Participants With Potentially Clinically Significant Vital Signs Findings | Maximum Increase from Baseline in DBP >=20 mmHg | 0 participants |
Other Pre-specified
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. The number of participants with specified skin AEs was reported.
Time frame: Baseline up to 28 days after last study drug administration (Day 21)
Population: The safety population included all enrolled participants who received at least 1 dose of investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263276 4% Solution | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin SAEs | 0 participants |
| PF-06263276 4% Solution | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin AEs | 0 participants |
| PF-06263276 Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin SAEs | 0 participants |
| PF-06263276 Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin AEs | 0 participants |
| Tofacitinib 2% Ointment | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin AEs | 0 participants |
| Tofacitinib 2% Ointment | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin SAEs | 0 participants |
| Tofacitinib Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin AEs | 0 participants |
| Tofacitinib Vehicle | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin SAEs | 0 participants |
| Daivonex Solution | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin AEs | 0 participants |
| Daivonex Solution | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin SAEs | 0 participants |
| Daivonex Ointment | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin SAEs | 0 participants |
| Daivonex Ointment | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs | Specified Skin AEs | 2 participants |