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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
Active ingredient-free vehicle to 4% solution
Daily Dosage: approximately 4 mg tofacitinib
Bioskin GmbH
Hamburg, Germany
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
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
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
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
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Active ingredient-free vehicle to 2% Ointment
Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg