Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic 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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-24

Study Completion Date

2019-03-20

Brief Summary

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The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.

Study Groups

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All subjects

All subjects will receive all six interventions/treatments applied to six different treatment fields.

Group Type OTHER

PF-06763809

Intervention Type DRUG

Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%

Vehicle

Intervention Type OTHER

Vehicle matching PF-06763809.

Calcipotriene/calcipotriol

Intervention Type DRUG

Calcipotriene/calcipotriol 50 ug/mL solution

Betamethasone

Intervention Type DRUG

Betamethasone 1 mg/g solution

Interventions

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PF-06763809

Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%

Intervention Type DRUG

Vehicle

Vehicle matching PF-06763809.

Intervention Type OTHER

Calcipotriene/calcipotriol

Calcipotriene/calcipotriol 50 ug/mL solution

Intervention Type DRUG

Betamethasone

Betamethasone 1 mg/g solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

Exclusion Criteria

* History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
* Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
* Treatment with any biologics within 3 months prior to Day 1 of the study and during the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No