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

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ClinicalTrials.gov Identifier: NCT02616250
Recruitment Status : Completed
First Posted : November 26, 2015
Results First Posted : October 19, 2017
Last Update Posted : March 12, 2018
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rosacea
Interventions Drug: Brimonidine 0.33% gel (Br)
Other: CD07805/47 (Br) placebo gel
Drug: Ivermectin 1% cream (IVM)
Other: CD5024 (IVM) placebo cream
Enrollment 190
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
Hide 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
Arm/Group Title Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream Total
Hide 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 Number of Baseline Participants 95 95 190
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 95 participants 95 participants 190 participants
51.0  (14.8) 48.0  (13.6) 50.0  (14.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 95 participants 95 participants 190 participants
Female
28
  29.5%
25
  26.3%
53
  27.9%
Male
67
  70.5%
70
  73.7%
137
  72.1%
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):
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 95 95
Measure Type: Count of Participants
Unit of Measure: Participants
53
  55.8%
35
  36.8%
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
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
Hide 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 (%) Affected / at Risk (%)
Total   0/95 (0.00%)      0/95 (0.00%)    
Show Serious Adverse Events Hide 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 (5.26%)      1/95 (1.05%)    
Cardiac disorders     
atrial fibrillation  1  1/95 (1.05%)  1 0/95 (0.00%)  0
Hepatobiliary disorders     
Biliary cirrhosis primary  1  1/95 (1.05%)  1 0/95 (0.00%)  0
Infections and infestations     
Pneumonia  1  0/95 (0.00%)  0 1/95 (1.05%)  1
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  1/95 (1.05%)  1 0/95 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/95 (1.05%)  1 0/95 (0.00%)  0
Squamous cell carcinoma  1  1/95 (1.05%)  1 0/95 (0.00%)  0
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
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 (8.42%)      13/95 (13.68%)    
Infections and infestations     
Upper respiratory tract infection  1  2/95 (2.11%)  5/95 (5.26%) 
nasopharyngitis  1  3/95 (3.16%)  5/95 (5.26%) 
Skin and subcutaneous tissue disorders     
erythema  1  3/95 (3.16%)  1/95 (1.05%) 
rosacea  1  0/95 (0.00%)  2/95 (2.11%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Fabien AUDIBERT, Sr CPM
Organization: GALDERMA
Phone: +33 (0) 4 9238 3034
EMail: fabien.audibert@galderma.com
Layout table for additonal information
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02616250     History of Changes
Other Study ID Numbers: RD.03.SPR.105069
First Submitted: November 24, 2015
First Posted: November 26, 2015
Results First Submitted: September 19, 2017
Results First Posted: October 19, 2017
Last Update Posted: March 12, 2018