Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

Phase 2

Completed

• Conditions: Erythemato-telangiectatic Rosacea
• Interventions: Drug: BFH772 1% ointment; Drug: Vehicle ointment; Drug: Noritate® 1% cream

• Registration Number: NCT01449591
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-19
• Study First Submitted QC: 2011-10-06
• Study First Posted: 2011-10-10
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-27
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFH772	BFH772 1% ointment	-
Vehicle	Vehicle ointment	-
Metronidazole	Noritate® 1% cream	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
To measure blood levels of BFH772 in patients	12 weeks
To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score	12 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇺🇸 Spokane, Washington, United States