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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

Tracking Information
First Submitted Date  ICMJE May 16, 2014
First Posted Date  ICMJE May 28, 2014
Results First Submitted Date  ICMJE May 7, 2015
Results First Posted Date  ICMJE September 30, 2015
Last Update Posted Date September 30, 2015
Study Start Date  ICMJE May 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2014)
Change in Investigator Global Assessment [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe
Change History Complete list of historical versions of study NCT02147691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2015)
  • 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
  • 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.
  • 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)
  • 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.
  • Lesion Count [ Time Frame: Week 4 ]
  • Lesion Counts [ Time Frame: Week 8 ]
  • Lesion Counts [ Time Frame: Week 12 ]
  • 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
  • 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
  • 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
  • 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
  • VAS [ Time Frame: Week 8 ]
    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
  • VAS [ Time Frame: Week 12 ]
    participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2014)
  • Lesion Counts [ Time Frame: Baseline, Week 4, Week 8 and Week 12 ]
    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 [ Time Frame: Baseline, Week 4, Week 8 and Week 12 ]
    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 VAS Assessment (Subject) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    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) [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: May 22, 2014)
Adverse events [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]
Through out the study, subjects will be monitored for signs and symptoms of adverse events. Adverse events will be collected regardless of whether related to study drug application or not.
 
Descriptive Information
Brief Title  ICMJE Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Official Title  ICMJE Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Rosacea
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Azelaic acid 15%
    • Drug: Brimonidine 0.33%
  • Active Comparator: Brimonidine 0.33% Gel
    Brimonidine 0.33% Gel
    Intervention: Drug: Brimonidine 0.33%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2015)
22
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2014)
20
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02147691
Other Study ID Numbers  ICMJE FIN1302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leon Kircik, M.D., Derm Research, PLLC
Study Sponsor  ICMJE Derm Research, PLLC
Collaborators  ICMJE Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators  ICMJE
Principal Investigator: Leon H. Kircik, M.D. DermResearch, PLLC
PRS Account Derm Research, PLLC
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP