ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02147691
Recruitment Status : Completed
First Posted : May 28, 2014
Results First Posted : September 30, 2015
Last Update Posted : September 30, 2015
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

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.

Condition or disease Intervention/treatment Phase
Acne Rosacea Drug: Azelaic acid 15% Drug: Brimonidine 0.33% Phase 4

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  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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 Name: Finacea

Drug: Brimonidine 0.33%
Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
Other Name: Miravaso

Active Comparator: Brimonidine 0.33% Gel
Brimonidine 0.33% Gel
Drug: Brimonidine 0.33%
Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
Other Name: Miravaso




Primary Outcome Measures :
  1. 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

  2. IGA [ Time Frame: Week 4 ]
    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

  3. IGA [ Time Frame: Week 8 ]
    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

  4. 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


Secondary Outcome Measures :
  1. Lesion Counts [ Time Frame: Baseline ]
    The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line

  2. Clinician's Erythema Assessment [ Time Frame: Baseline ]
    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.

  3. Erythema Visual Analog Scale (VAS) Assessment (Subject) [ Time Frame: Baseline ]
    Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable)

  4. Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline ]
    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.

  5. Lesion Count [ Time Frame: Week 4 ]
  6. Lesion Counts [ Time Frame: Week 8 ]
  7. Lesion Counts [ Time Frame: Week 12 ]
  8. Erythema [ Time Frame: Week 4 ]
    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

  9. Erythema [ Time Frame: Week 8 ]
    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

  10. Erythema [ Time Frame: Week 12 ]
    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

  11. Visual Analog Scale (VAS) [ Time Frame: Week 4 ]
    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

  12. VAS [ Time Frame: Week 8 ]
    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

  13. VAS [ Time Frame: Week 12 ]
    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable

  14. Dermatology Life Quality Index (DLQI) [ Time Frame: Week 4 ]
    Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

  15. DLQI [ Time Frame: Week 8 ]
    Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)

  16. DLQI [ Time Frame: Week 12 ]
    Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02147691


Locations
United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: Leon H. Kircik, M.D. DermResearch, PLLC

Responsible Party: Leon Kircik, M.D., Medical Director, Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT02147691     History of Changes
Other Study ID Numbers: FIN1302
First Posted: May 28, 2014    Key Record Dates
Results First Posted: September 30, 2015
Last Update Posted: September 30, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Brimonidine Tartrate
Azelaic acid
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antineoplastic Agents
Dermatologic Agents