Trial Outcomes & Findings for A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice (NCT NCT03337490)
NCT ID: NCT03337490
Last Updated: 2020-09-17
Results Overview
The primary endpoint is the proportion of index subjects who are lice free at Day 15
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
296 participants
Primary outcome timeframe
15 Days
Results posted on
2020-09-17
Participant Flow
Participant milestones
| Measure |
Ivermectin 0.5% Lotion
Ivermectin 0.5% lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Ivermectin 0.5% Lotion [SKLICE]
Sklice 0.5% Lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion \[SKLICE\]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Placebo 0% Lotion
0% lotion, 117g, single dose
Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
|
|---|---|---|---|
|
Overall Study
STARTED
|
128
|
126
|
42
|
|
Overall Study
COMPLETED
|
117
|
112
|
7
|
|
Overall Study
NOT COMPLETED
|
11
|
14
|
35
|
Reasons for withdrawal
| Measure |
Ivermectin 0.5% Lotion
Ivermectin 0.5% lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Ivermectin 0.5% Lotion [SKLICE]
Sklice 0.5% Lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion \[SKLICE\]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Placebo 0% Lotion
0% lotion, 117g, single dose
Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
10
|
12
|
35
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
Baseline characteristics by cohort
| Measure |
Ivermectin 0.5% Lotion
n=128 Participants
Ivermectin 0.5% lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Ivermectin 0.5% Lotion [SKLICE]
n=125 Participants
Sklice 0.5% Lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion \[SKLICE\]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Placebo 0% Lotion
n=42 Participants
0% lotion, 117g, single dose
Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
|
Total
n=295 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
1 Month-2 Years
|
2 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Customized
2-12 Years
|
89 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
189 Participants
n=4 Participants
|
|
Age, Customized
12-16 Years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
|
Age, Customized
=>16 Years
|
15 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
208 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
272 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other/missing
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
102 Participants
n=5 Participants
|
105 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
242 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Missing
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
128 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
|
Head Lice Visual Assessment
|
128 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
295 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 15 DaysThe primary endpoint is the proportion of index subjects who are lice free at Day 15
Outcome measures
| Measure |
Ivermectin 0.5% Lotion
n=115 Participants
Ivermectin 0.5% lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Ivermectin 0.5% Lotion [SKLICE]
n=111 Participants
Sklice 0.5% Lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion \[SKLICE\]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Placebo 0% Lotion
n=40 Participants
0% lotion, 117g, single dose
Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
|
|---|---|---|---|
|
The Proportion of Index Subjects Who Are Lice Free at Day 15
|
106 Participants
|
98 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 DaysThe secondary endpoint includes the number of all index subjects who are lice-free at Day 2
Outcome measures
| Measure |
Ivermectin 0.5% Lotion
n=115 Participants
Ivermectin 0.5% lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Ivermectin 0.5% Lotion [SKLICE]
n=111 Participants
Sklice 0.5% Lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion \[SKLICE\]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Placebo 0% Lotion
n=40 Participants
0% lotion, 117g, single dose
Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
|
|---|---|---|---|
|
The Number of All Index Subjects Who Are Lice-free at Day 2
|
112 Participants
|
109 Participants
|
10 Participants
|
Adverse Events
Ivermectin 0.5% Lotion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ivermectin 0.5% Lotion [SKLICE]
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo 0% Lotion
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ivermectin 0.5% Lotion
n=128 participants at risk
Ivermectin 0.5% lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion: Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Ivermectin 0.5% Lotion [SKLICE]
n=125 participants at risk
Sklice 0.5% Lotion, topical, 117g, single dose
Ivermectin 0.5% Topical Application Lotion \[SKLICE\]: Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
|
Placebo 0% Lotion
n=42 participants at risk
0% lotion, 117g, single dose
Placebo 0% Lotion: Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/128 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
0.00%
0/125 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
2.4%
1/42 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
|
General disorders
Upper Resporitory Tract Infection
|
0.00%
0/128 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
0.00%
0/125 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
2.4%
1/42 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/128 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
0.80%
1/125 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
0.00%
0/42 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
|
Infections and infestations
Influenza
|
0.00%
0/128 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
1.6%
2/125 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
0.00%
0/42 • 2.5 months from first subject first visit.
No deaths or serious adverse events occurred during the duration of this study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place