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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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One Arm

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

Group Type EXPERIMENTAL

PF06263276

Intervention Type DRUG

4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD

Vehicle

Intervention Type OTHER

Active ingredient-free vehicle to 4% solution

2%Tofacitinib Ointment

Intervention Type DRUG

Daily Dosage: approximately 4 mg tofacitinib

Vehicle

Intervention Type OTHER

Active ingredient-free vehicle to 2% Ointment

Daivonex

Intervention Type DRUG

Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

Daivonex Ointment

Intervention Type DRUG

Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

Interventions

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PF06263276

4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD

Intervention Type DRUG

Vehicle

Active ingredient-free vehicle to 4% solution

Intervention Type OTHER

2%Tofacitinib Ointment

Daily Dosage: approximately 4 mg tofacitinib

Intervention Type DRUG

Vehicle

Active ingredient-free vehicle to 2% Ointment

Intervention Type OTHER

Daivonex

Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

Intervention Type DRUG

Daivonex Ointment

Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No