Back to resultsMirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. (MOSAIC)
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Brimonidine 0.33% gel (Br)
CD07805/47 (Br) placebo gel
Ivermectin 1% cream (IVM)
CD5024 (IVM) placebo cream
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
Main Inclusion Criteria:
- Male or female subjects age 18 years or older;
- Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
- Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]);
- Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]);
- Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
- Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
- Females subjects of non-childbearing potential;
Main Exclusion Criteria:
- Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
- Subjects with more than 2 nodules of rosacea on the face;
- Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
- Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream
Arm Description
Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks. Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
Outcomes
Primary Outcome Measures
Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02616250
Brief Title
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
Acronym
MOSAIC
Official Title
Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
Arm Type
Experimental
Arm Description
Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.
Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
Arm Title
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream
Arm Type
Placebo Comparator
Arm Description
Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Brimonidine 0.33% gel (Br)
Intervention Type
Other
Intervention Name(s)
CD07805/47 (Br) placebo gel
Intervention Type
Drug
Intervention Name(s)
Ivermectin 1% cream (IVM)
Intervention Type
Other
Intervention Name(s)
CD5024 (IVM) placebo cream
Primary Outcome Measure Information:
Title
Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
Description
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
Time Frame
week 12/Hour 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Male or female subjects age 18 years or older;
Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]);
Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]);
Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
Females subjects of non-childbearing potential;
Main Exclusion Criteria:
Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
Subjects with more than 2 nodules of rosacea on the face;
Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
Facility Information:
City
Fort Smith
State/Province
Arkansas
Country
United States
City
Rogers
State/Province
Arkansas
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
New York
State/Province
New York
Country
United States
City
Pflugerville
State/Province
Texas
Country
United States
City
Surrey
State/Province
British Columbia
Country
Canada
City
Markham
State/Province
Ontario
Country
Canada
City
Peterborough
State/Province
Ontario
Country
Canada
City
Richmond Hill
State/Province
Ontario
Country
Canada
City
Waterloo
State/Province
Ontario
Country
Canada
City
Windsor
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
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