Trial Outcomes & Findings for A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation (NCT NCT01066585)
NCT ID: NCT01066585
Last Updated: 2012-04-06
Results Overview
Treatment success defined as absence of live lice, was assessed in index participants, 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
410 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 8 March 2010 to 9 June 2010 in 8 US clinical centers.
A total of 410 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
|
211
|
199
|
|
Overall Study
COMPLETED
|
210
|
196
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
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
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
Baseline Characteristics
A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation
Baseline characteristics by cohort
| Measure |
0.5% Ivermectin
n=211 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=199 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
Total
n=410 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
164 Participants
n=93 Participants
|
149 Participants
n=4 Participants
|
313 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
97 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age Continuous
|
13.92 Years
STANDARD_DEVIATION 12.00 • n=93 Participants
|
15.05 Years
STANDARD_DEVIATION 13.52 • n=4 Participants
|
14.47 Years
STANDARD_DEVIATION 12.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=93 Participants
|
164 Participants
n=4 Participants
|
336 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
211 Participants
n=93 Participants
|
199 Participants
n=4 Participants
|
410 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Day 2 up to Day 15 post-applicationPopulation: Treatment success 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.
Treatment success defined as absence of live lice, was assessed in index participants, 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=71 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)
|
76 Percent of Participants
|
16 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)
|
76 Percent of Participants
|
15 Percent of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 2 up to Day 15 post-applicationPopulation: Treatment success 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.
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=211 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=199 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)
|
82 Percent of Participants
|
22 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)
|
81 Percent of Participants
|
21 Percent of Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 up to Day 15 post-application.Population: Adverse events were assessed in the Intent-to-treat (Safety) population.
Severity of the 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=210 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=199 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 Lymphadenopathy
|
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 Lymphadenopathy
|
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 Eye Irritation
|
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 Eye Irritation
|
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 Impetigo
|
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 Impetigo
|
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 Pharyngitis Streptococcal
|
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 Pharyngitis Streptococcal
|
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 Tonsillitis
|
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 Tonsillitis
|
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
|
0 Participants
|
4 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 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 Erythema
|
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 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 Pruritis
|
3 Participants
|
4 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
|
|
Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Skin Burning Sensation
|
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 Skin Burning Sensation
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 1 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=211 Participants
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
|
Vehicle Control
n=199 Participants
Participants underwent a single treatment with vehicle control cream at home on Day 1.
|
|---|---|---|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 1 (Pre-treatment; N = 211, 199)
|
126 Participants
|
136 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Puritus Day 1 (Pre-treatment; N = 211, 199)
|
7 Participants
|
10 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 2 (N = 210, 199)
|
41 Participants
|
98 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 2 (N = 210, 199)
|
2 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 8 (N = 203, 77)
|
31 Participants
|
10 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 8 (N = 203, 77)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 15 (N = 197, 51)
|
12 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 15 (N = 197, 51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 1 (Pre-treatment; N = 211, 199)
|
16 Participants
|
23 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 1 (Pre-treatment; N= 211, 199)
|
0 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 2 (N = 210, 199)
|
14 Participants
|
22 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 2 (N = 210, 199)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 8 (N = 203, 77)
|
8 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 8 (N = 203, 77)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 15 (N = 197, 51)
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 15 (N = 197, 51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 1 (Pre-treatment; N= 211, 199)
|
16 Participants
|
48 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 1 (Pre-treatment; N=211,199
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 2 (N = 210, 199)
|
14 Participants
|
34 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 2 (N = 210, 199)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 8 (N = 203, 77)
|
3 Participants
|
8 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 8 (N = 203, 77)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 15 (N = 197, 51)
|
1 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 15 (N = 197, 51)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 1 (Pre-treatment; N = 211, 199)
|
0 Participants
|
3 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 1 (Pre-treatment; N= 211, 199)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 2 (N = 210, 199)
|
0 Participants
|
3 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 2 (N = 210, 199)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 8 (N = 203, 77)
|
0 Participants
|
1 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 8 (N = 203, 77)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 15 (N = 197, 51)
|
0 Participants
|
0 Participants
|
|
Summary of the Reported Skin/Scalp Irritation Before Treatment and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 15 (N = 197, 51)
|
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