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OpenTrials
Completed

NCT Number: NCT01449591

Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

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.

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Key information

Conditions

Erythemato-telangiectatic Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Hot Springs, Arkansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BFH772 1% ointment

Drug

Vehicle ointment

Drug

Noritate® 1% cream

Drug

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

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. To measure blood levels of BFH772 in patients

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Proof of Concept (PoC) Study to Evaluate the Safety, Tolerability, and Efficacy of 12 Week Administration of BFH772 Ointment in Rosacea Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 10, 2011
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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