Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01449591
First received: September 19, 2011
Last updated: April 27, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Erythemato-telangiectatic Rosacea
Drug: BFH772 1% ointment
Drug: Vehicle ointment
Drug: Noritate® 1% cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To measure blood levels of BFH772 in patients [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: September 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BFH772 Drug: BFH772 1% ointment
Placebo Comparator: Vehicle Drug: Vehicle ointment
Active Comparator: Metronidazole Drug: Noritate® 1% cream

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01449591

Locations
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
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01449591     History of Changes
Other Study ID Numbers: CBFH772A2203
Study First Received: September 19, 2011
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
BFH772
rosacea
erythemato-telangiectatic rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014