Trial Outcomes & Findings for Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation (NCT NCT00857948)
NCT ID: NCT00857948
Last Updated: 2012-03-30
Results Overview
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
78 participants
Primary outcome timeframe
Day 1 through Day 15 post-application
Results posted on
2012-03-30
Participant Flow
Participants were enrolled and treated on 14 March 2009 in 1 US clinical center.
A total of 78 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participant milestones
| Measure |
0.15% Ivermectin
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
19
|
23
|
|
Overall Study
COMPLETED
|
15
|
18
|
18
|
23
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
0.15% Ivermectin
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
1
|
0
|
Baseline Characteristics
Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
Baseline characteristics by cohort
| Measure |
0.15% Ivermectin
n=18 Participants
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
n=18 Participants
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
n=19 Participants
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
n=23 Participants
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age Continuous
Age Continuous
|
12.28 Years
STANDARD_DEVIATION 13.00 • n=5 Participants
|
14.11 Years
STANDARD_DEVIATION 8.71 • n=7 Participants
|
14.21 Years
STANDARD_DEVIATION 12.87 • n=5 Participants
|
11.13 Years
STANDARD_DEVIATION 8.73 • n=4 Participants
|
12.83 Years
STANDARD_DEVIATION 10.79 • n=21 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
78 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day 1 through Day 15 post-applicationPopulation: Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Outcome measures
| Measure |
0.15% Ivermectin
n=18 Participants
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
n=18 Participants
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
n=19 Participants
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
n=23 Participants
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
|
56 Percent of participants
|
50 Percent of participants
Interval 0.0 to 0.0
|
74 Percent of participants
Interval 0.0 to 0.0
|
9 Percent of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 8 post-applicationPopulation: Live lice eradication was assessed in the Intent-to-treat Population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.
Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Outcome measures
| Measure |
0.15% Ivermectin
n=18 Participants
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
n=18 Participants
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
n=19 Participants
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
n=23 Participants
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 2 hours post-application
|
33 Percent of participants
|
44 Percent of participants
Interval 0.0 to 0.0
|
32 Percent of participants
Interval 0.0 to 0.0
|
22 Percent of participants
Interval 0.0 to 0.0
|
|
Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 6 hours post-application
|
50 Percent of participants
|
67 Percent of participants
Interval 0.0 to 0.0
|
58 Percent of participants
Interval 0.0 to 0.0
|
30 Percent of participants
Interval 0.0 to 0.0
|
|
Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 2
|
83 Percent of participants
|
94 Percent of participants
Interval 0.0 to 0.0
|
95 Percent of participants
Interval 0.0 to 0.0
|
17 Percent of participants
Interval 0.0 to 0.0
|
|
Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8
|
67 Percent of participants
|
72 Percent of participants
Interval 0.0 to 0.0
|
84 Percent of participants
Interval 0.0 to 0.0
|
9 Percent of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 through Day 15 post-applicationPopulation: The level of lice infestation was assessed in the Intent-to-treat population. Any participant with live lice on or after Day 2 received an FDA approved head lice treatment and was classified as a treatment failure, imputed as such for remaining assessments.
The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe \> 20 live lice.
Outcome measures
| Measure |
0.15% Ivermectin
n=18 Participants
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
n=18 Participants
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
n=19 Participants
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
n=23 Participants
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 2 Hours Post Dose: None
|
33 Percent of participants
|
44 Percent of participants
Interval 0.0 to 0.0
|
32 Percent of participants
Interval 0.0 to 0.0
|
22 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 2 Hours Post Dose: Mild
|
50 Percent of participants
|
56 Percent of participants
Interval 0.0 to 0.0
|
63 Percent of participants
Interval 0.0 to 0.0
|
65 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 2 Hours Post Dose: Moderate
|
17 Percent of participants
|
0 Percent of participants
Interval 0.0 to 0.0
|
5 Percent of participants
Interval 0.0 to 0.0
|
13 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 6 Hours Post Dose: None
|
50 Percent of participants
|
67 Percent of participants
Interval 0.0 to 0.0
|
58 Percent of participants
Interval 0.0 to 0.0
|
30 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 6 Hours Post Dose: Mild
|
39 Percent of participants
|
33 Percent of participants
Interval 0.0 to 0.0
|
37 Percent of participants
Interval 0.0 to 0.0
|
61 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 1: 6 Hours Post Dose: Moderate
|
11 Percent of participants
|
0 Percent of participants
Interval 0.0 to 0.0
|
5 Percent of participants
Interval 0.0 to 0.0
|
9 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 2: None
|
83 Percent of participants
|
94 Percent of participants
Interval 0.0 to 0.0
|
95 Percent of participants
Interval 0.0 to 0.0
|
17 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 2: Mild
|
17 Percent of participants
|
6 Percent of participants
Interval 0.0 to 0.0
|
5 Percent of participants
Interval 0.0 to 0.0
|
78 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 2: Moderate
|
0 Percent of participants
|
0 Percent of participants
Interval 0.0 to 0.0
|
0 Percent of participants
Interval 0.0 to 0.0
|
4 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8: Treatment Failure Day 2
|
17 Percent of participants
|
6 Percent of participants
Interval 0.0 to 0.0
|
5 Percent of participants
Interval 0.0 to 0.0
|
83 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8: None
|
72 Percent of participants
|
72 Percent of participants
Interval 0.0 to 0.0
|
84 Percent of participants
Interval 0.0 to 0.0
|
9 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8: Mild
|
11 Percent of participants
|
6 Percent of participants
Interval 0.0 to 0.0
|
5 Percent of participants
Interval 0.0 to 0.0
|
9 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8: Moderate
|
0 Percent of participants
|
6 Percent of participants
Interval 0.0 to 0.0
|
0 Percent of participants
Interval 0.0 to 0.0
|
0 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8: Severe
|
0 Percent of participants
|
11 Percent of participants
Interval 0.0 to 0.0
|
5 Percent of participants
Interval 0.0 to 0.0
|
0 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15: Treatment Failure Day 8
|
33 Percent of participants
|
28 Percent of participants
Interval 0.0 to 0.0
|
16 Percent of participants
Interval 0.0 to 0.0
|
91 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15: None
|
56 Percent of participants
|
56 Percent of participants
Interval 0.0 to 0.0
|
74 Percent of participants
Interval 0.0 to 0.0
|
9 Percent of participants
Interval 0.0 to 0.0
|
|
Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15: Mild
|
11 Percent of participants
|
17 Percent of participants
Interval 0.0 to 0.0
|
11 Percent of participants
Interval 0.0 to 0.0
|
0 Percent of participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 28 post-applicationPopulation: Adverse events were assess in the Safety (Intent-to-treat) Population.
Outcome measures
| Measure |
0.15% Ivermectin
n=18 Participants
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
n=18 Participants
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
n=19 Participants
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
n=23 Participants
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Conjunctivitis
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Severe Conjunctivitis
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Eye Pruritus
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Severe Eye Pruritus
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Erythema
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Severe Erythema
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Folliculitis
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Severe Folliculitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Pruritus
|
5 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Severe Pruritus
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Skin Irritation
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control).
Severe Skin Irritation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
0.15% Ivermectin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
0.25% Ivermectin
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
0.50% Ivermectin
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.15% Ivermectin
n=18 participants at risk
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
|
0.25% Ivermectin
n=18 participants at risk
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
|
0.50% Ivermectin
n=19 participants at risk
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
|
Placebo
n=23 participants at risk
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/18 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/18 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/23 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
|
Eye disorders
Eye Pruritus
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/18 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/19 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/23 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/18 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
13.0%
3/23 • Number of events 3 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
0.00%
0/18 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
5.6%
1/18 • Number of events 1 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
0.00%
0/19 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.8%
5/18 • Number of events 5 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
11.1%
2/18 • Number of events 2 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
21.1%
4/19 • Number of events 4 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
4.3%
1/23 • Number of events 1 • Adverse event data were collected from Day 1 up to Day 28 post-application.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
- Publication restrictions are in place
Restriction type: OTHER