Clinical trial NCT02147691: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Rosacea
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
Collaborators: name: Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
First posted: 2014-05-28
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Investigator Global Assessment (IGA) at Baseline
timeFrame: Baseline
measure: IGA
timeFrame: Week 4
measure: IGA
timeFrame: Week 8
measure: IGA
timeFrame: Week 12
Secondary outcomes:
measure: Lesion Counts
timeFrame: Baseline
measure: Clinician's Erythema Assessment
timeFrame: Baseline
measure: Erythema Visual Analog Scale (VAS) Assessment (Subject)
timeFrame: Baseline
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Baseline
measure: Lesion Count
timeFrame: Week 4
measure: Lesion Counts
timeFrame: Week 8
measure: Lesion Counts
timeFrame: Week 12
measure: Erythema
timeFrame: Week 4
measure: Erythema
timeFrame: Week 8
measure: Erythema
timeFrame: Week 12
measure: Visual Analog Scale (VAS)
timeFrame: Week 4
measure: VAS
timeFrame: Week 8
measure: VAS
timeFrame: Week 12
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Week 4
measure: DLQI
timeFrame: Week 8
measure: DLQI
timeFrame: Week 12
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
affiliation: DermResearch, PLLC
name: Leon H. Kircik, M.D.
role: PRINCIPAL_INVESTIGATOR
References: