Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

Erythemato-telangiectatic Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01449591
• Other study ID #: CBFH772A2203
• Status: Completed
• Phase: Phase 2
• Start date: September 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Erythemato-telangiectatic Rosacea
• Rosacea

Intervention

Drug:
• BFH772 1% ointment

• Vehicle ointment

• Noritate® 1% cream

Locations

Country	Name	City	State
United States	Novartis Investigative Site	Ann Arbor	Michigan
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Hot Springs	Arkansas
United States	Novartis Investigative Site	Paramus	New Jersey
United States	Novartis Investigative Site	Portland	Oregon
United States	Novartis Investigative Site	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the effect of BFH772 treatment compared to vehicle on non-transient facial erythema using the Investigator's assessment of facial erythema score		12 weeks
Secondary	To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score		12 weeks
Secondary	To measure blood levels of BFH772 in patients		12 weeks

External Links

•   Results for CBFH772A2203 from the Novartis Clinical Trials website