Trial Outcomes & Findings for A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects (NCT NCT01068158)
NCT ID: NCT01068158
Last Updated: 2012-04-06
Results Overview
Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
371 participants
Primary outcome timeframe
Day 2 up to Day 15 post-application
Results posted on
2012-04-06
Participant Flow
Participants were enrolled and treated from 4 March 2010 to 17 June 2010 in 8 US clinical centers.
A total of 371 participants who met the inclusion and exclusion criteria were enrolled and treated.
Participant milestones
| Measure |
0.5% Ivermectin
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
169
|
202
|
|
Overall Study
COMPLETED
|
161
|
198
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
| Measure |
0.5% Ivermectin
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
7
|
0
|
|
Overall Study
Protocol Violation
|
0
|
2
|
Baseline Characteristics
A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects
Baseline characteristics by cohort
| Measure |
0.5% Ivermectin
n=169 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=202 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
Total
n=371 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
126 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
276 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age Continuous
|
14.37 Years
STANDARD_DEVIATION 13.33 • n=5 Participants
|
15.19 Years
STANDARD_DEVIATION 13.85 • n=7 Participants
|
14.82 Years
STANDARD_DEVIATION 13.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
169 Participants
n=5 Participants
|
202 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 2 up to Day 15 post-applicationPopulation: Treatment success was assessed in a subset of the Intent-to-treat population (Index participants). 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.
Treatment success, defined as absence of live lice, was assessed in index subjects, defined as the youngest person within each household who had at least 3 live lice present at Screening (Day 1). Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Outcome measures
| Measure |
0.5% Ivermectin
n=70 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=74 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15 (LOCF Imputation)
|
71 Percent of Participants
|
19 Percent of Participants
Interval 0.0 to 0.0
|
|
Percentage of Index Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15 (Treatment Failure Imputation)
|
69 Percent of Participants
|
18 Percent of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 2 up to Day 15 post-applicationPopulation: Treatment success was assessed in the Intent-to-treat 2 (All Participants) 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.
Treatment success, defined as absence of live lice, was assessed in all subjects. Treatment success was assessed by last observation carried forward (LOCF) imputation and treatment failure imputation.
Outcome measures
| Measure |
0.5% Ivermectin
n=169 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=202 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15 (LOCF Imputation)
|
78 Percent of Participants
|
23 Percent of Participants
Interval 0.0 to 0.0
|
|
Percentage of All Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15 (Treatment Failure Imputation)
|
72 Percent of Participants
|
21 Percent of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 2 up to Day 15 post-applicationPopulation: Adverse events were assessed in the Intent-to-treat (Safety) 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.
Adverse events were defined and classified as follows: 'Mild' - Awareness of signs or symptoms, but easily tolerated; 'Moderate' - Discomfort to a degree that adverse event/adverse drug reaction causes interference with normal daily life activities and/or requires medication; 'Severe' - Incapacity with regard to work or usual daily life activities. Requires medical attention/intervention.
Outcome measures
| Measure |
0.5% Ivermectin
n=169 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=202 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Conjunctivitis
|
1 Participants
|
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
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Ocular Hyperemia
|
1 Participants
|
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 Ocular Hyperemia
|
0 Participants
|
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)
Any Toothache
|
1 Participants
|
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 Toothache
|
0 Participants
|
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)
Any Vomiting
|
0 Participants
|
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 Vomiting
|
0 Participants
|
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)
Any Pyrexia
|
0 Participants
|
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 Pyrexia
|
0 Participants
|
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)
Any Otitis Media
|
0 Participants
|
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 Otitis Media
|
0 Participants
|
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)
Any Excoriation
|
1 Participants
|
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 Excoriation
|
0 Participants
|
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)
Any Injury
|
0 Participants
|
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 Injury
|
0 Participants
|
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)
Any Scratch
|
0 Participants
|
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 Scratch
|
0 Participants
|
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)
Any Musculoskeletal Pain
|
0 Participants
|
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 Musculoskeletal Pain
|
0 Participants
|
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)
Any Pain in Extremity
|
0 Participants
|
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 Pain in Extremity
|
0 Participants
|
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)
Any Cough
|
1 Participants
|
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 Cough
|
0 Participants
|
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)
Any Dandruff
|
1 Participants
|
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 Dandruff
|
0 Participants
|
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)
Any Dry Skin
|
1 Participants
|
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 Dry Skin
|
0 Participants
|
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)
Any Erythema
|
2 Participants
|
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
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus
|
0 Participants
|
2 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 Pruritus
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 2 up to Day 15 post-applicationPopulation: Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.
Severe skin/scalp irritations were defined as follows: Severe Pruritus - Nearly constant, frequent scratching, very bothersome; Severe Erythema - large areas of the scalp are red; Severe Excoriation - Widespread breaking of the skin involving most of the scalp; Severe Pyoderma - Lesions with crusting or other evidence of infection, involving most of the scalp.
Outcome measures
| Measure |
0.5% Ivermectin
n=169 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=202 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 1 (Pre-treatment; N = 169, 202)
|
124 Participants
|
147 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 1 (Pre-treatment; N= 169, 202)
|
12 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 2 (N = 166, 200)
|
55 Participants
|
104 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 2 (N = 166, 200)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 8 (N = 148, 58)
|
19 Participants
|
14 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 8 (N = 148, 58)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 15 (N = 142, 53)
|
13 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 15 (N = 142, 53)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Erythema Day 1 (Pre-treatment; N = 169, 202)
|
45 Participants
|
53 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 1 (Pre-treatment; N= 169, 202)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 2 (N = 166, 200)
|
31 Participants
|
41 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 2 (N = 166, 200)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 8 (N = 148, 58)
|
8 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 8 (N = 148, 58)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 15 (N = 142, 53)
|
4 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 15 (N = 142, 53)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 1 (Pre-treatment; N= 169, 202)
|
42 Participants
|
46 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 1 (Pre-treatment N=169, 202
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 2 (N = 166, 200)
|
36 Participants
|
46 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 2 (N = 166, 200)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 8 (N = 148, 58)
|
13 Participants
|
5 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 8 (N = 148, 58)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 15 (N = 142, 53)
|
5 Participants
|
4 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 15 (N = 142, 53)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 1 (Pre-treatment; N= 169, 202)
|
3 Participants
|
2 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 1 (Pre-treatment; N= 169, 202)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 2 (N = 166, 200)
|
3 Participants
|
2 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 2 (N = 166, 200)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 8 (N = 148, 58)
|
1 Participants
|
1 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 8 (N = 148, 58)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 15 (N = 142, 53)
|
2 Participants
|
1 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 15 (N = 142, 53)
|
0 Participants
|
0 Participants
|
Adverse Events
0.5% Ivermectin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle Control
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 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