Phase 4
Completed N=22
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study
Acne Rosacea
Source: ClinicalTrials.gov NCT02147691 ↗
Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Investigator Global Assessment (IGA) at Baseline — 3; 3.1 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Investigator Global Assessment (IGA) at Baseline |
3; 3.1 | — |
| PRIMARY IGA |
1.3; 1.4 | — |
| SECONDARY Lesion Counts |
0.7; 1.2 | — |
| SECONDARY Clinician's Erythema Assessment |
2.3; 2.1 | — |
| SECONDARY Erythema Visual Analog Scale (VAS) Assessment (Subject) |
5.5; 5.6 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) |
1.8; 2.6 | — |
| SECONDARY Lesion Count |
1.1; 2.1 | — |
| SECONDARY Erythema |
1.3; 1.2 | — |
| SECONDARY Visual Analog Scale (VAS) |
4.5; 5.2 | — |
| SECONDARY VAS |
3.8; 4.0 | — |
| SECONDARY DLQI |
1.2; 2.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT02147691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.