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

Condition(s) targeted: Acne Rosacea

Intervention: Azelaic acid 15% (Drug); Brimonidine 0.33% (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Derm Research, PLLC

Official(s) and/or principal investigator(s):
Leon H. Kircik, M.D., Principal Investigator, Affiliation: DermResearch, PLLC

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Change in Investigator Global Assessment

Secondary outcome:

Lesion counts

Clinician's Erythema assessment

Erythema VAS Assessment (Subject)

Dermatology Life Quality Index (DLQI)

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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

DermResearch, PLLC, Louisville, Kentucky 40217, United States

Starting date: May 2014
Last updated: February 13, 2015