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

Derm Research, PLLC22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acne Rosacea

Interventions

Azelaic acid 15%DRUG

Applied to the face each AM and PM

Brimonidine 0.33%DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

DermResearch, PLLC

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Investigator Global Assessment (IGA) at Baseline

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Time frame: Baseline

IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Time frame: Week 4

IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Time frame: Week 8

IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

Time frame: Week 12

Secondary Outcomes

Lesion Counts

The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line

Time frame: Baseline

Clinician's Erythema Assessment

Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured.

Time frame: Baseline

Erythema Visual Analog Scale (VAS) Assessment (Subject)

Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)

Time frame: Baseline

Dermatology Life Quality Index (DLQI)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.