Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Erythemato-telangiectatic Rosacea

Treatments: Drug: BFH772 1% ointment; Drug: Vehicle ointment; Drug: Noritate® 1% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT01449591

CBFH772A2203

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 3 patient groups, including a placebo group

BFH772

Experimental group

Treatment:

Drug: BFH772 1% ointment

Vehicle

Placebo Comparator group

Treatment:

Drug: Vehicle ointment

Metronidazole

Active Comparator group

Treatment:

Drug: Noritate® 1% cream