Trial Outcomes & Findings for Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea (NCT NCT02795117)
NCT ID: NCT02795117
Last Updated: 2021-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
486 participants
Primary outcome timeframe
Day 1 to Day 84
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Test Product
Ivermectin cream
|
Reference Product
Ivermectin (reference) cream
|
Placebo
Placebo cream
|
|---|---|---|---|
|
Overall Study
STARTED
|
193
|
193
|
100
|
|
Overall Study
COMPLETED
|
175
|
166
|
88
|
|
Overall Study
NOT COMPLETED
|
18
|
27
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Safety and Efficacy of Two Treatments in the Treatment of Inflammatory Lesions of Rosacea
Baseline characteristics by cohort
| Measure |
Test Product
n=193 Participants
Ivermectin Cream, 1% (Perrigo)
|
Reference Product
n=193 Participants
Ivermectin Cream, 1% (reference)
|
Placebo
n=100 Participants
Placebo cream
|
Total
n=486 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51.9 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 13.61 • n=7 Participants
|
51.2 years
STANDARD_DEVIATION 14.25 • n=5 Participants
|
51.5 years
STANDARD_DEVIATION 13.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
348 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
392 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
188 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
474 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 84Population: Per protocol population
Outcome measures
| Measure |
Test Product
n=156 Participants
Ivermectin cream
|
Reference Product
n=147 Participants
Ivermectin (reference) cream
|
Placebo
n=75 Participants
Placebo cream
|
|---|---|---|---|
|
Mean Percent Change From Baseline in the Inflammatory (Papules and Pustules) Lesion Count
|
65.47 percentage of lesion reduction
Standard Deviation 30.222
|
67.89 percentage of lesion reduction
Standard Deviation 30.244
|
55.51 percentage of lesion reduction
Standard Deviation 32.660
|
SECONDARY outcome
Timeframe: Day 1 to Day 84Population: Per protocol population
Clinical success is defined as a score of clear or almost clear
Outcome measures
| Measure |
Test Product
n=156 Participants
Ivermectin cream
|
Reference Product
n=147 Participants
Ivermectin (reference) cream
|
Placebo
n=75 Participants
Placebo cream
|
|---|---|---|---|
|
Subjects With Clinical Success on the Investigator Global Assessment
|
71 Participants
|
79 Participants
|
26 Participants
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER