MOSAIC: MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02616250
• Collaborator: (none)
• Enrollment: 190
• Locations: 13
• Arms: 2
• Duration (Months): 9
• Patients Per Site: 14.6
• Patients Per Site Per Month: 1.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Drug: Ivermectin 1% cream (IVM); Other: CD5024 (IVM) placebo cream	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2015
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream 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.	Drug: Brimonidine 0.33% gel (Br); Other: CD07805/47 (Br) placebo gel; Drug: Ivermectin 1% cream (IVM)
Placebo Comparator: CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.	Other: CD07805/47 (Br) placebo gel; Other: CD5024 (IVM) placebo cream

Outcome Measures

Primary Outcome Measures

1. Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): [week 12/Hour 3]

   Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Main Inclusion Criteria:

1. Male or female subjects age 18 years or older;

2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;

3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]);

4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]);

5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);

6. Female subjects of childbearing potential must practice a highly effective method of contraception during the study;

7. Females subjects of non-childbearing potential;

Main Exclusion Criteria:

1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;

2. Subjects with more than 2 nodules of rosacea on the face;

3. 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;

4. 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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Fort Smith	Arkansas	United States
2		Rogers	Arkansas	United States
3		Sacramento	California	United States
4		Orlando	Florida	United States
5		Omaha	Nebraska	United States
6		New York	New York	United States
7		Pflugerville	Texas	United States
8		Surrey	British Columbia	Canada
9		Markham	Ontario	Canada
10		Peterborough	Ontario	Canada
11		Richmond Hill	Ontario	Canada
12		Waterloo	Ontario	Canada
13		Windsor	Ontario	Canada

Sponsors and Collaborators

• Galderma R&D

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT02616250
• Other Study ID Numbers: RD.03.SPR.105069
• First Posted: Nov 26, 2015
• Last Update Posted: Feb 18, 2021
• Last Verified: Feb 1, 2018

• Additional relevant MeSH terms: Rosacea; Ivermectin; Brimonidine Tartrate

Study Results

Participant Flow

Arm/Group Title	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream	CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
Arm/Group 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. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM)	Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream
Period Title: Overall Study
STARTED	95	95
COMPLETED	85	86
NOT COMPLETED	10	9

Baseline Characteristics

Arm/Group Title	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream	CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream	Total
Arm/Group 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. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM)	Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream	Total of all reporting groups
Overall Participants	95	95	190
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.0 (14.8)	48.0 (13.6)	50.0 (14.2)
Sex: Female, Male (Count of Participants)
Female	28 29.5%	25 26.3%	53 27.9%
Male	67 70.5%	70 73.7%	137 72.1%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Intent To Treat (ITT) Population

Arm/Group Title	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream	CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
Arm/Group 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. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM)	Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream
Measure Participants	95	95
Count of Participants [Participants]	53 55.8%	35 36.8%

Adverse Events

Time Frame	All AEs occurring after subject's consent and during the study were recorded; 3 months for a given subject 10 months for the study; ie: from first subject enrolled until last visit of last subject enrolled
Arm/Group Title	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream		CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
Arm/Group 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. Brimonidine 0.33% gel (Br) CD07805/47 (Br) placebo gel Ivermectin 1% cream (IVM)		Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks. CD07805/47 (Br) placebo gel CD5024 (IVM) placebo cream
All Cause Mortality
	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream		CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/95 (0%)
Serious Adverse Events
	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream		CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/95 (5.3%)		1/95 (1.1%)
Cardiac disorders
atrial fibrillation	1/95 (1.1%)	1	0/95 (0%)	0
Hepatobiliary disorders
Biliary cirrhosis primary	1/95 (1.1%)	1	0/95 (0%)	0
Infections and infestations
Pneumonia	0/95 (0%)	0	1/95 (1.1%)	1
Metabolism and nutrition disorders
Type 2 diabetes mellitus	1/95 (1.1%)	1	0/95 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma	1/95 (1.1%)	1	0/95 (0%)	0
Squamous cell carcinoma	1/95 (1.1%)	1	0/95 (0%)	0
Other (Not Including Serious) Adverse Events
	Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream		CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	8/95 (8.4%)		13/95 (13.7%)
Infections and infestations
Upper respiratory tract infection	2/95 (2.1%)		5/95 (5.3%)
nasopharyngitis	3/95 (3.2%)		5/95 (5.3%)
Skin and subcutaneous tissue disorders
erythema	3/95 (3.2%)		1/95 (1.1%)
rosacea	0/95 (0%)		2/95 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.