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A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02193815
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 16, 2014
First Posted Date  ICMJE July 18, 2014
Results First Submitted Date  ICMJE March 4, 2016
Results First Posted Date  ICMJE June 9, 2016
Last Update Posted Date June 9, 2016
Study Start Date  ICMJE September 2014
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
Change from baseline in psoriatic skin thickness using 4% solution of PF-06263276 in comparison to vehicle. [ Time Frame: 11 days of treatment ]
Assessed using 20 MHz sonographic measurement
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2016)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Change from baseline in psoriatic skin thickness using 4% solution of PF-06263276 in comparison to Daivonex solution (50 ug/ml). [ Time Frame: 11 days of treatment ]
    Assessed using 20 MHz sonographic measurement
  • Change from baseline in psoriatic skin thickness using 2% ointment of Tofacitinib in comparison to vehicle. [ Time Frame: 11 days of treatment ]
    Assessed using 20 MHz sonographic measurement
  • Change from baseline in psoriatic skin thickness [ Time Frame: 7 days of treatment ]
    Assessed using 20 MHz sonographic measurement
  • Area Under the Curve from Time Zero to end of dosing interval (AUCtau) [ Time Frame: 11 days of treatment ]
    Assessed using 20 MHz sonographic measurement
  • Global Clinical Assessment [ Time Frame: Study Days 1, 8 and 12 ]
    Visual examination using a 5 point score
Current Other Pre-specified Outcome Measures
 (submitted: May 2, 2016)
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis Vulgaris
Intervention  ICMJE
  • Drug: PF06263276
    4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
  • Other: Vehicle
    Active ingredient-free vehicle to 4% solution
  • Drug: 2%Tofacitinib Ointment
    Daily Dosage: approximately 4 mg tofacitinib
  • Other: Vehicle
    Active ingredient-free vehicle to 2% Ointment
  • Drug: Daivonex
    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
Study Arms  ICMJE Experimental: One Arm
Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment
Interventions:
  • Drug: PF06263276
  • Other: Vehicle
  • Drug: 2%Tofacitinib Ointment
  • Other: Vehicle
  • Drug: Daivonex
  • Drug: Daivonex Ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)
15
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2014)
20
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02193815
Other Study ID Numbers  ICMJE B5391003
2014-000068-16 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP