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

Derm Research

Status and phase: Completed; Phase 4

Conditions: Acne Rosacea

Treatments: Drug: Azelaic acid 15%; Drug: Brimonidine 0.33%

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02147691

FIN1302

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Azelaic acid 15%, Brimonidine 0.33 % Gel

Experimental group

Description:

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

Treatment:

Drug: Brimonidine 0.33%

Drug: Azelaic acid 15%

Brimonidine 0.33% Gel

Active Comparator group

Description:

Brimonidine 0.33% Gel

Treatment:

Drug: Brimonidine 0.33%