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Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study

NCT ID: NCT02147691

Last Updated: 2015-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2015-02-28

Brief Summary

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The pilot study will investigate whether combination treatment of Finacea 15% Gel and Brimonidine 0.33% Gel could be more effective than Brimonidine 0.33% Gel monotherapy in treating both the papules/pustules and erythema associated with rosacea.

Detailed Description

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Acne rosacea is a chronic inflammatory disease with different components including inflammatory lesions (papules/pustules), erythema and telangiectasia. Brimonidine 0.33% Gel primarily affects the erythematous components of rosacea. As such, combination treatment with a standard rosacea treatment, such as Finacea 15% Gel, may provide additional relief for the inflammatory component of rosacea.

Conditions

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Acne Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Azelaic acid 15%, Brimonidine 0.33 % Gel

Azelaic acid 15% to the face each AM followed 30 minutes later by Brimonidine 0.33%

Azelaic acid 15% to the face each PM

Group Type EXPERIMENTAL

Azelaic acid 15%

Intervention Type DRUG

Applied to the face each AM and PM

Brimonidine 0.33%

Intervention Type DRUG

Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Brimonidine 0.33% Gel

Brimonidine 0.33% Gel

Group Type ACTIVE_COMPARATOR

Brimonidine 0.33%

Intervention Type DRUG

Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Interventions

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Azelaic acid 15%

Applied to the face each AM and PM

Intervention Type DRUG

Brimonidine 0.33%

Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Intervention Type DRUG

Other Intervention Names

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Finacea Miravaso

Eligibility Criteria

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Inclusion Criteria

* Male or Female
* 18 years of age and older
* Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline
* Female subjects of childbearing potential must practice a reliable method of contraception throughout the study
* Moderate or severe rosacea with an Investigator Global Assessment (IGA) score of 3 or 4
* Able to understand and comply with the requirements of the study and sign Informed Consent/Health Insurance Portability and Accountability Authorization forms

Exclusion Criteria

* Female subjects who are pregnant, breast feeding or who are of childbearing potential and not practicing a reliable method of birthcontrol
* History of hypersensitivity or idiosyncratic reaction to any component of the test medications
* Subjects who have not completed the proper wash-out periods for prohibited medications and/or procedures
* Medical condition that contraindicates the subject's participation in the study
* Alcohol or drug abuse is evident within the past 5 years
* History of poor cooperation, non-compliance with medical treatment, unreliability
* Participation in an investigational drug study within 30 days of the Baseline visit
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role collaborator

Derm Research, PLLC

OTHER

Sponsor Role lead

Responsible Party

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Leon Kircik, M.D.

Medical Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leon H. Kircik, M.D.

Role: PRINCIPAL_INVESTIGATOR

DermResearch, PLLC

Locations

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DermResearch, PLLC

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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FIN1302

Identifier Type: -

Identifier Source: org_study_id