Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

February 17, 2021 updated by: Novartis Pharmaceuticals

A Proof of Concept (PoC) Study to Evaluate the Safety, Tolerability, and Efficacy of 12 Week Administration of BFH772 Ointment in Rosacea Patients

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States
        • Novartis Investigative Site
    • Michigan
      • Ann Arbor, Michigan, United States
        • Novartis Investigative Site
    • New Jersey
      • Paramus, New Jersey, United States
        • Novartis Investigative Site
    • Oregon
      • Portland, Oregon, United States
        • Novartis Investigative Site
    • Texas
      • Austin, Texas, United States
        • Novartis Investigative Site
    • Washington
      • Spokane, Washington, United States
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Drug: Vehicle ointment
Experimental: BFH772
Drug: BFH772 1% ointment
Active Comparator: Metronidazole
Drug: Noritate® 1% cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks
To measure blood levels of BFH772 in patients
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

September 19, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (Estimate)

October 10, 2011

Study Record Updates

Last Update Posted (Actual)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBFH772A2203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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