Clinical trial NCT02193815: A 12 Day Study To Evaluate A Topical Drug To Treat Plaque Psoriasis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Keywords: psoriasis
plaque
vulgaris
phase 1
randomized
double-blind
topical
safety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Psoriatic Skin Thickness/Echo-Poor Band (EPB) for PF-06263276 4% Solution in Comparison to Corresponding Vehicle at Day 12
timeFrame: Day 1 (Baseline), Day 12
Secondary outcomes:
measure: Change From Baseline in Psoriatic Skin Thickness/EPB for PF-06263276 4% Solution in Comparison to Daivonex Solution at Day 12
timeFrame: Day 1 (Baseline), Day 12
measure: Change From Baseline in Psoriatic Skin Thickness/EPB for Tofacitinib 2% Ointment in Comparison to Corresponding Vehicle at Day 12
timeFrame: Day 1 (Baseline), Day 12
measure: Change From Baseline in Psoriatic Skin Thickness/EPB at Day 8
timeFrame: Day 1 (Baseline), Day 8
measure: Area Under the Curve (AUC) of Psoriatic Skin Thickness/EPB
timeFrame: Day 1 (baseline) up to Day 12
measure: Global Clinical Assessment at Day 1, 8 and 12
timeFrame: Day 1, Day 8, Day 12
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Specified Skin AEs
timeFrame: Baseline up to 28 days after last study drug administration (Day 21)
measure: Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
timeFrame: Baseline up to Day 12
measure: Number of Participants With Potentially Clinically Significant Vital Signs Findings
timeFrame: Baseline up to Day 12
Locations:
city: Hamburg
country: Germany
facility: Bioskin GmbH
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: