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

Acne Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147691
• Other study ID #: FIN1302
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2014
• Last updated: August 28, 2015
• Start date: May 2014
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Derm Research, PLLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Acne Rosacea
• Rosacea

Intervention

Drug:
• Azelaic acid 15%
Applied to the face each AM and PM
• Brimonidine 0.33%
Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Locations

Country	Name	City	State
United States	DermResearch, PLLC	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Derm Research, PLLC	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	IGA	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe	Week 4	No
Primary	IGA	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe	Week 8	No
Primary	IGA	Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe	Week 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Lesion Count		Week 4	No
Secondary	Lesion Counts		Week 8	No
Secondary	Lesion Counts		Week 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	VAS	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable	Week 8	No
Secondary	VAS	participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable	Week 12	No
Secondary	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	No
Secondary	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	No
Secondary	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	No