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Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01449591
Recruitment Status : Completed
First Posted : October 10, 2011
Last Update Posted : March 28, 2017
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Erythemato-telangiectatic Rosacea Drug: BFH772 1% ointment Drug: Vehicle ointment Drug: Noritate® 1% cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Proof of Concept (PoC) Study to Evaluate the Safety, Tolerability, and Efficacy of 12 Week Administration of BFH772 Ointment in Rosacea Patients
Study Start Date : September 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
  2. To measure blood levels of BFH772 in patients [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01449591

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United States, Arkansas
Novartis Investigative Site
Hot Springs, Arkansas, United States
United States, Michigan
Novartis Investigative Site
Ann Abor, Michigan, United States
United States, New Jersey
Novartis Investigative Site
Paramus, New Jersey, United States
United States, Oregon
Novartis Investigative Site
Portland, Oregon, United States
United States, Texas
Novartis Investigative Site
Austin, Texas, United States
United States, Washington
Novartis Investigative Site
Spokane, Washington, United States
Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT01449591    
Other Study ID Numbers: CBFH772A2203
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
erythemato-telangiectatic rosacea
Additional relevant MeSH terms:
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Skin Diseases