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

Browse trials for

• Psoriasis 1,928
• Plaque, Amyloid 97

Keywords

• psoriasis
• plaque
• vulgaris
• phase 1
• randomized
• double-blind
• topical
• safety

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's enrollment of 15 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Study arms

• Experimental
  One Arm

  Study treatments 1-6 Study drug, vehicle, Tofacitinib, vehicle, Daivonex solution and ointment

  Drug: PF06263276 · Other: Vehicle · Drug: 2%Tofacitinib Ointment · Drug: Daivonex · Drug: Daivonex Ointment

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

• OtherVehicle

  Active ingredient-free vehicle to 2% Ointment

• 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

Primary outcomes

1. 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

Secondary outcomes

1. 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

2. 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

3. Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8

   Time frame: Day 1 (Baseline), Day 8

4. 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

5. 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

Other outcomes

1. 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)

2. 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

3. 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

Baseline characteristics

Related links

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