Trial Outcomes & Findings for MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea. (NCT NCT02616250)
NCT ID: NCT02616250
Last Updated: 2021-02-18
Results Overview
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
190 participants
Primary outcome timeframe
week 12/Hour 3
Results posted on
2021-02-18
Participant Flow
Participant milestones
| Measure |
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.
Brimonidine 0.33% gel (Br)
CD07805/47 (Br) placebo gel
Ivermectin 1% cream (IVM)
|
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.
CD07805/47 (Br) placebo gel
CD5024 (IVM) placebo cream
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
95
|
|
Overall Study
COMPLETED
|
85
|
86
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.
Baseline characteristics by cohort
| Measure |
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream
n=95 Participants
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)
|
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
n=95 Participants
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
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.0 years
STANDARD_DEVIATION 14.8 • n=5 Participants
|
48.0 years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
50.0 years
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 12/Hour 3Population: Intent To Treat (ITT) Population
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
Outcome measures
| Measure |
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream
n=95 Participants
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)
|
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
n=95 Participants
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
|
|---|---|---|
|
Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
|
53 Participants
|
35 Participants
|
Adverse Events
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream
n=95 participants at risk
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)
|
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
n=95 participants at risk
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
|
|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
1.1%
1/95 • Number of events 1 • 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
|
0.00%
0/95 • 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
|
|
Hepatobiliary disorders
Biliary cirrhosis primary
|
1.1%
1/95 • Number of events 1 • 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
|
0.00%
0/95 • 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
|
|
Infections and infestations
Pneumonia
|
0.00%
0/95 • 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
|
1.1%
1/95 • Number of events 1 • 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
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
1.1%
1/95 • Number of events 1 • 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
|
0.00%
0/95 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.1%
1/95 • Number of events 1 • 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
|
0.00%
0/95 • 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
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.1%
1/95 • Number of events 1 • 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
|
0.00%
0/95 • 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
|
Other adverse events
| Measure |
Brimonidine 0.33% Gel / CD07805/47 (Br) + Ivermectin 1% Cream
n=95 participants at risk
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)
|
CD07805/47 (Br) Placebo Gel + CD5024 (IVM) Placebo Cream
n=95 participants at risk
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
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
2/95 • 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
|
5.3%
5/95 • 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
|
|
Infections and infestations
nasopharyngitis
|
3.2%
3/95 • 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
|
5.3%
5/95 • 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
|
|
Skin and subcutaneous tissue disorders
erythema
|
3.2%
3/95 • 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
|
1.1%
1/95 • 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
|
|
Skin and subcutaneous tissue disorders
rosacea
|
0.00%
0/95 • 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
|
2.1%
2/95 • 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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place