Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Derm Research, PLLC
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- IGA
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Azelaic acid 15% (Drug)
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
Intervention: Brimonidine 0.33% (Drug)
Brimonidine 0.33% Gel
Brimonidine 0.33% Gel
Intervention: Brimonidine 0.33% (Drug)
Outcomes
Primary Outcomes
IGA
Time Frame: Week 12
Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Investigator Global Assessment (IGA) at Baseline
Time Frame: Baseline
Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Secondary Outcomes
- Visual Analog Scale (VAS)(Week 4)
- Clinician's Erythema Assessment(Baseline)
- Lesion Count(Week 4)
- Erythema(Week 12)
- VAS(Week 12)
- Lesion Counts(Week 12)
- Erythema Visual Analog Scale (VAS) Assessment (Subject)(Baseline)
- Dermatology Life Quality Index (DLQI)(Week 4)
- DLQI(Week 12)
Investigators
Leon Kircik, M.D.
Medical Director
Derm Research, PLLC