Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

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

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-02-29

Brief Summary

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This study will evaluate the safety, tolerability and efficacy of BFH772 after 12 weeks of treatment as compared to an active control and vehicle in patients with erythemato-telangiectatic rosacea.

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Detailed Description

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Conditions

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Erythemato-telangiectatic Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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BFH772

Group Type EXPERIMENTAL

BFH772 1% ointment

Intervention Type DRUG

Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle ointment

Intervention Type DRUG

Metronidazole

Group Type ACTIVE_COMPARATOR

Noritate® 1% cream

Intervention Type DRUG

Interventions

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BFH772 1% ointment

Intervention Type DRUG

Vehicle ointment

Intervention Type DRUG

Noritate® 1% cream

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Have persistent facial erythema on the cheeks of at least moderate severity.
* Women must not be able to bear children

Exclusion Criteria

* Have more than 12 inflammatory lesions on the face
* Previous treatment of facial skin with lasers or electrocauterisation within 2 months prior to entering the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No