Safety and Efficacy of BFH772 in Psoriasis Patients

NCT ID: NCT00987870

Last Updated: 2011-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Brief Summary

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This study will determine the efficacy of topical BFH772 in psoriasis patients and the safety after multiple dosing.

Detailed Description

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Conditions

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Psoriasis Arthritis

Keywords

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Stable plaque Psoriasis inflammatory skin with or without arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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BFH772 cream 1%

Group Type EXPERIMENTAL

BFH772

Intervention Type DRUG

Placebo to BFH772 cream 1%

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

BFH772 ointment 1%

Group Type EXPERIMENTAL

BFH772

Intervention Type DRUG

Placebo to BFH772 ointment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

calcipotriol/betamethasone ointment

Group Type ACTIVE_COMPARATOR

calcipotriol/betamethasone

Intervention Type DRUG

Interventions

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BFH772

Intervention Type DRUG

Placebo

Intervention Type DRUG

BFH772

Intervention Type DRUG

Placebo

Intervention Type DRUG

calcipotriol/betamethasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Stable mild to moderate plaque psoriasis (BSA involvement \< 10% or PASI \< 10
* Category "mild to moderate" on PGA as according to the EMEA (CHMP 2004) (Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis), with or without arthritis
* Diagnosed or history of psoriasis for at least 6 months prior to screening

Exclusion Criteria

* Nonplaque forms of psoriasis
* Drug-induced psoriasis
* Current use of beta blockers
* Congestive heart failure (NYHA \>III), QT interval \>450msec or poorly controlled diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigator Site

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EUDRACT No. 2008-002795-96

Identifier Type: -

Identifier Source: secondary_id

CBFH772A2201

Identifier Type: -

Identifier Source: org_study_id