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Completed

NCT Number: NCT02147691

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.

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Key information

Conditions

Acne Rosacea Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Azelaic acid 15%

Drug

Applied to the face each AM and PM

Other names: Finacea

Brimonidine 0.33%

Drug

Applied to the face each AM 30 minutes after the application of Azelaic acid 15%

Other names: Miravaso

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Derm Research, PLLC

Other

Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 28, 2014
Registry last updated
Sep 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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