Trial Outcomes & Findings for Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects (NCT NCT00994422)
NCT ID: NCT00994422
Last Updated: 2012-04-06
Results Overview
Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
264 participants
Primary outcome timeframe
Days 2 up to Day 15 post-treatment
Results posted on
2012-04-06
Participant Flow
Participants were enrolled and treated from 13 October 2009 to 02 December 2009 in 12 US clinical centers.
A total of 247 of the 264 randomized participants who met the inclusion and exclusion criteria received treatment in the study.
Participant milestones
| Measure |
0.5% Ivermectin
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
Participants received a single application of vehicle control cream on Day 1.
|
|---|---|---|
|
Overall Study
STARTED
|
192
|
55
|
|
Overall Study
COMPLETED
|
185
|
54
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
Reasons for withdrawal
| Measure |
0.5% Ivermectin
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
Participants received a single application of vehicle control cream on Day 1.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
1
|
Baseline Characteristics
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=192 Participants
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
n=55 Participants
Participants received a single application of vehicle control cream on Day 1.
|
Total
n=247 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
147 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
15.9 Years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
19.6 Years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
16.76 Years
STANDARD_DEVIATION 13.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
161 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
203 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
192 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Days 2 up to Day 15 post-treatmentPopulation: 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 was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.
Outcome measures
| Measure |
0.5% Ivermectin
n=192 Participants
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
n=55 Participants
Participants received a single application of vehicle control cream on Day 1.
|
|---|---|---|
|
Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 2 (N = 192, 55)
|
95 Percent of Participants
|
53 Percent of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 8 (N = 191, 55)
|
83 Percent of Participants
|
49 Percent of Participants
Interval 0.0 to 0.0
|
|
Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)
Day 15 (N = 185, 54)
|
76 Percent of Participants
|
35 Percent of Participants
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Day 1 up to Day 28 post-applicationPopulation: Adverse events were assessed in the Intent-to-treat (Safety) population.
Outcome measures
| Measure |
0.5% Ivermectin
n=192 Participants
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
n=55 Participants
Participants received a single application of vehicle control cream on Day 1.
|
|---|---|---|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Conjunctivitis
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Application site pruritus
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Influenza
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Nail bed infection
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Pharyngitis
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Pyoderma
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Swine influenza
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Upper respiratory tract infection
|
5 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Contusion
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Excoriation
|
8 Participants
|
4 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Scratch
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Headache
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Asthma
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Dyspnoea
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Oropharyngeal pain
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Erythema
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Pruritus
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Rash maculo-papular
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to Day 15 post-applicationPopulation: Local tolerability was assessed in the Intent-to-treat (Safety) population.
Participants skin/scalp irritations were assessed before treatment (Day 1) and Post-treatment with either Ivermectin or placebo by a trained evaluator. Severe 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=192 Participants
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
n=55 Participants
Participants received a single application of vehicle control cream on Day 1.
|
|---|---|---|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 1 (Pre-treatment; N = 192, 55)
|
26 Participants
|
5 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 1 (Pre-treatment; N = 192, 55)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 2 (N = 192, 55)
|
18 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 2 (N = 192, 55)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 8 (N = 181, 29)
|
7 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 8 (N = 181, 29)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Erythema Day 15 (N = 152, 26)
|
3 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Erythema Day 15 (N = 152, 26)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 1 (Pre-treatment; N = 192, 55)
|
31 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 1 (Pre-treatment; N=192, 55
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 2 (N = 192, 55)
|
27 Participants
|
7 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 2 (N = 192, 55)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 8 (N = 181, 29)
|
15 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 8 (N = 181, 29)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Excoriation Day 15 (N = 152, 26)
|
4 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Excoriation Day 15 (N = 152, 26)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 1 (Pre-treatment; N = 192, 55)
|
134 Participants
|
36 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 1 (Pre-treatment; N = 192, 55)
|
17 Participants
|
3 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 2 (N = 192, 55)
|
56 Participants
|
25 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 2 (N = 192, 55)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 8 (N = 181, 29)
|
32 Participants
|
5 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 8 (N = 181, 29)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pruritus Day 15 (N = 152, 26)
|
8 Participants
|
2 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pruritus Day 15 (N = 152, 26)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 1 (Pre-treatment, N = 192, 55)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 1 (Pre-treatment; N = 192, 55)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 2 (N = 192, 55)
|
1 Participants
|
1 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 2 (N = 192, 55)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 8 (N = 181, 29)
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 8 (N = 181, 29)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Any Pyoderma Day 15 (N = 152, 26)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
|
Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Severe Pyoderma Day 15 (N = 152, 26)
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
Adverse Events
0.5% Ivermectin
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Placebo (Vehicle Control)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.5% Ivermectin
n=192 participants at risk
Participants received a single application of Ivermectin cream on Day 1.
|
Placebo (Vehicle Control)
n=55 participants at risk
Participants received a single application of vehicle control cream on Day 1.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Excoriation
|
4.2%
8/192 • Adverse event data were collected form Day 1 up to Day 28 post-treatment with either Ivermectin or Placebo
|
7.3%
4/55 • Adverse event data were collected form Day 1 up to Day 28 post-treatment with either Ivermectin or Placebo
|
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