Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

NCT01449591 | Completed Phase 2

• 1 other identifier: CBFH772A2203
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 6

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.

Conditions

Erythemato-telangiectatic Rosacea

Keywords

BFH772; rosacea; erythemato-telangiectatic rosacea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate a patient's assessment of flushing frequency via patient reported episodes and facial redness via a patient reported score

  12 weeks

• To measure blood levels of BFH772 in patients

  12 weeks

Study Arms (3)

BFH772

EXPERIMENTAL

Drug: BFH772 1% ointment

Vehicle

PLACEBO COMPARATOR

Drug: Vehicle ointment

Metronidazole

ACTIVE COMPARATOR

Drug: Noritate® 1% cream

Interventions

BFH772 1% ointment DRUG

BFH772

Vehicle ointment DRUG

Vehicle

Noritate® 1% cream DRUG

Metronidazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have persistent facial erythema on the cheeks of at least moderate severity.
• Women must not be able to bear children

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

Hot Springs, Arkansas, United States

Location

Novartis Investigative Site

Ann Arbor, Michigan, United States

Location

Novartis Investigative Site

Paramus, New Jersey, United States

Location

Novartis Investigative Site

Portland, Oregon, United States

Location

Novartis Investigative Site

Austin, Texas, United States

Location

Novartis Investigative Site

Spokane, Washington, United States

Location

Related Links

• Results for CBFH772A2203 from the Novartis Clinical Trials website

MeSH Terms

Conditions

Rosacea

Interventions

Ointments; Benchmarking

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Management Audit; Organization and Administration; Health Services Administration; Program Evaluation; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2011
• First Posted: October 10, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

US (6)