NCT02147691

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 30, 2015

Completed
Last Updated

September 30, 2015

Status Verified

August 1, 2015

Enrollment Period

8 months

First QC Date

May 16, 2014

Results QC Date

May 7, 2015

Last Update Submit

August 28, 2015

Conditions

Acne Rosacea

Outcome Measures

Primary Outcomes (4)

  • Investigator Global Assessment (IGA) at Baseline

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Baseline

  • IGA

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Week 4

  • IGA

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Week 8

  • IGA

    Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe

    Week 12

Secondary Outcomes (16)

  • Lesion Counts

    Baseline

  • Clinician's Erythema Assessment

    Baseline

  • Erythema Visual Analog Scale (VAS) Assessment (Subject)

    Baseline

  • Dermatology Life Quality Index (DLQI)

    Baseline

  • Lesion Count

    Week 4

  • +11 more secondary outcomes

Study Arms (2)

Azelaic acid 15%, Brimonidine 0.33 % Gel

EXPERIMENTAL

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%Drug: Brimonidine 0.33%

Brimonidine 0.33% Gel

ACTIVE COMPARATOR

Brimonidine 0.33% Gel

Drug: Brimonidine 0.33%

Interventions

Azelaic acid 15%DRUG

Applied to the face each AM and PM

Also known as: Finacea
Azelaic acid 15%, Brimonidine 0.33 % Gel
Brimonidine 0.33%DRUG

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

Also known as: Miravaso
Azelaic acid 15%, Brimonidine 0.33 % GelBrimonidine 0.33% Gel

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DermResearch, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

Pilot study. Small number of participants.

Results Point of Contact

Title
Leon H. Kircik, M.D.
Organization
DermResearch, PLLC
wedoderm@yahoo.com
502-451-9000

Study Officials

  • Leon H. Kircik, M.D.

    DermResearch, PLLC

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 28, 2014

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

September 30, 2015

Results First Posted

September 30, 2015

Record last verified: 2015-08

Locations

US(1)