Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

Novartis Pharmaceuticals36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Erythemato-telangiectatic Rosacea

Interventions

BFH772 1% ointmentDRUG

Vehicle ointmentDRUG

Noritate® 1% creamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 * Have facial hair that makes it difficult to evaluate rosacea on the face Other protocol-defined inclusion/exclusion criteria may apply

Locations (6)

Novartis Investigative Site

Hot Springs, Arkansas, United States

Novartis Investigative Site

Ann Arbor, Michigan, United States

Novartis Investigative Site

Paramus, New Jersey, United States

Novartis Investigative Site

Portland, Oregon, United States

Outcomes

Primary Outcomes

To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score

Time frame: 12 weeks

Secondary Outcomes

To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score

Time frame: 12 weeks

To measure blood levels of BFH772 in patients

Time frame: 12 weeks

Data from ClinicalTrials.gov

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