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Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

Primary Purpose

Erythemato-telangiectatic Rosacea

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BFH772 1% ointment
Vehicle ointment
Noritate® 1% cream
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythemato-telangiectatic Rosacea focused on measuring BFH772, rosacea, erythemato-telangiectatic rosacea

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

BFH772

Vehicle

Metronidazole

Arm Description

Outcomes

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

Secondary Outcome Measures

To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score
To measure blood levels of BFH772 in patients

Full Information

First Posted
September 19, 2011
Last Updated
February 17, 2021
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01449591
Brief Title
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients
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 Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythemato-telangiectatic Rosacea
Keywords
BFH772, rosacea, erythemato-telangiectatic rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFH772
Arm Type
Experimental
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Title
Metronidazole
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BFH772 1% ointment
Intervention Type
Drug
Intervention Name(s)
Vehicle ointment
Intervention Type
Drug
Intervention Name(s)
Noritate® 1% cream
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
To measure blood levels of BFH772 in patients
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Novartis Investigative Site
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
Novartis Investigative Site
City
Paramus
State/Province
New Jersey
Country
United States
Facility Name
Novartis Investigative Site
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Novartis Investigative Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Novartis Investigative Site
City
Spokane
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7963
Description
Results for CBFH772A2203 from the Novartis Clinical Trials website

Learn more about this trial

Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

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