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

Primary Purpose

Acne Rosacea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Azelaic acid 15%
Brimonidine 0.33%
Sponsored by
Derm Research, PLLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Rosacea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • DermResearch, PLLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Azelaic acid 15%, Brimonidine 0.33 % Gel

Brimonidine 0.33% Gel

Arm 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

Brimonidine 0.33% Gel

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Lesion Counts
The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line
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.
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)
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.
Lesion Count
Lesion Counts
Lesion Counts
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
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
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
Visual Analog Scale (VAS)
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
VAS
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
VAS
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
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)
DLQI
Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
DLQI
Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

Full Information

First Posted
May 16, 2014
Last Updated
August 28, 2015
Sponsor
Derm Research, PLLC
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02147691
Brief Title
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Official Title
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derm Research, PLLC
Collaborators
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Rosacea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Azelaic acid 15%, Brimonidine 0.33 % Gel
Arm Type
Experimental
Arm 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
Arm Title
Brimonidine 0.33% Gel
Arm Type
Active Comparator
Arm Description
Brimonidine 0.33% Gel
Intervention Type
Drug
Intervention Name(s)
Azelaic acid 15%
Other Intervention Name(s)
Finacea
Intervention Description
Applied to the face each AM and PM
Intervention Type
Drug
Intervention Name(s)
Brimonidine 0.33%
Other Intervention Name(s)
Miravaso
Intervention Description
Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
Primary Outcome Measure Information:
Title
Investigator Global Assessment (IGA) at Baseline
Description
Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Time Frame
Baseline
Title
IGA
Description
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
Title
IGA
Description
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
Title
IGA
Description
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 Outcome Measure Information:
Title
Lesion Counts
Description
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
Title
Clinician's Erythema Assessment
Description
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
Title
Erythema Visual Analog Scale (VAS) Assessment (Subject)
Description
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
Title
Dermatology Life Quality Index (DLQI)
Description
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.
Time Frame
Baseline
Title
Lesion Count
Time Frame
Week 4
Title
Lesion Counts
Time Frame
Week 8
Title
Lesion Counts
Time Frame
Week 12
Title
Erythema
Description
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
Time Frame
Week 4
Title
Erythema
Description
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
Time Frame
Week 8
Title
Erythema
Description
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
Time Frame
Week 12
Title
Visual Analog Scale (VAS)
Description
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame
Week 4
Title
VAS
Description
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame
Week 8
Title
VAS
Description
participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
Time Frame
Week 12
Title
Dermatology Life Quality Index (DLQI)
Description
Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame
Week 4
Title
DLQI
Description
Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame
Week 8
Title
DLQI
Description
Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon H. Kircik, M.D.
Organizational Affiliation
DermResearch, PLLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States

12. IPD Sharing Statement

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

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