A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
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|ClinicalTrials.gov Identifier: NCT02193815|
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Psoriasis Vulgaris||Drug: PF06263276 Other: Vehicle Drug: 2%Tofacitinib Ointment Drug: Daivonex Drug: Daivonex Ointment||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 1, Single- Center, Randomized, Double-blind, Vehicle And Active Comparator-controlled Trial To Evaluate The Antipsoriatic Activity And Safety Of A Topically Applied Pf-06263276 Formulation In A Psoriasis Plaque Test|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
Experimental: One Arm
Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment
4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
Active ingredient-free vehicle to 4% solution
Drug: 2%Tofacitinib Ointment
Daily Dosage: approximately 4 mg tofacitinib
Active ingredient-free vehicle to 2% Ointment
Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Drug: Daivonex Ointment
Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
- Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12 [ Time Frame: 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.
- 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 ]
- 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 ]
- Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8 [ Time Frame: Day 1 (Baseline), Day 8 ]
- Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB [ Time Frame: 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 [ Time Frame: 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).
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs [ Time Frame: 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.
- Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern [ Time Frame: 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 Potentially Clinically Significant Vital Signs Findings [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02193815
|Hamburg, Germany, 20095|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|