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

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.

Study Overview

• Status: Completed
• Conditions: Acne Rosacea
• Intervention / Treatment: Drug: Azelaic acid 15%; Drug: Brimonidine 0.33%

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • DermResearch, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Azelaic acid 15%; Applied to the face each AM and PM; Other Names: Finacea; Drug: Brimonidine 0.33%; Applied to the face each AM 30 minutes after the application of Azelaic acid 15%; Other Names: Miravaso
Active Comparator: Brimonidine 0.33% Gel	Drug: Brimonidine 0.33%; Applied to the face each AM 30 minutes after the application of Azelaic acid 15%; Other Names: Miravaso

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
IGA	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe	Week 4
IGA	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe	Week 8
IGA	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Counts	The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line	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.	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)	Baseline
Dermatology Life Quality Index (DLQI)	The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible.	Baseline
Lesion Count		Week 4
Lesion Counts		Week 8
Lesion Counts		Week 12
Erythema	Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red	Week 4
Erythema	Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red	Week 8
Erythema	Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red	Week 12
Visual Analog Scale (VAS)	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable	Week 4
VAS	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable	Week 8
VAS	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable	Week 12
Dermatology Life Quality Index (DLQI)	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)	Week 4
DLQI	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)	Week 8
DLQI	Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)	Week 12

Collaborators and Investigators

• Sponsor: Derm Research, PLLC
• Collaborators: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
• Investigators: Principal Investigator: Leon H. Kircik, M.D., DermResearch, PLLC

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 16, 2014
• First Submitted That Met QC Criteria: May 22, 2014
• First Posted (Estimate): May 28, 2014

Study Record Updates

• Last Update Posted (Estimate): September 30, 2015
• Last Update Submitted That Met QC Criteria: August 28, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Antineoplastic Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Brimonidine Tartrate; Azelaic acid
• Other Study ID Numbers: FIN1302

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No