Safety, Tolerability and Efficacy of BFH772 in Rosacea Pa... | NCT01449591

Studies
Safety, Tolerability and Efficacy of BFH772 in Rosacea Patients

NCT01449591

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Feb 21, 2021Actual

Enrollment

36Actual

Phase

Phase 2

Conditions

Erythemato-telangiectatic Rosacea

Interventions

BFH772 1% ointment
Vehicle ointment
Noritate® 1% cream

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Feb 2012Actual

Completion Date

Feb 2012Actual

First Submitted Date

Sep 19, 2011

First Submission Date that Met QC Criteria

Oct 6, 2011

First Posted Date

Oct 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Aug 20, 2020

Certification/Extension First Submitted that Passed QC Review

Aug 20, 2020

Certification/Extension First Posted Date

Aug 27, 2020Actual

Last Update Submitted Date

Feb 17, 2021

Last Update Posted Date

Feb 21, 2021Actual

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
BFH772	Experimental	Drug: BFH772 1% ointment
Vehicle	Placebo Comparator	Drug: Vehicle ointment
Metronidazole	Active Comparator	Drug: Noritate® 1% cream

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BFH772 1% ointment	Drug		BFH772
Vehicle ointment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Hot Springs	Arkansas		United States
Novartis Investigative Site

References Module

Citations

Not provided

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D009824	Ointments
D019985	Benchmarking

ID	Term
D004304	Dosage Forms
D004364	Pharmaceutical Preparations
D008330	Management Audit
D009934	Organization and Administration