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Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects

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ClinicalTrials.gov Identifier: NCT00994422
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : April 4, 2012
Last Update Posted : April 6, 2012
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Head Lice
Interventions Drug: Ivermectin cream
Drug: vehicle control
Enrollment 264
Recruitment Details Participants were enrolled and treated from 13 October 2009 to 02 December 2009 in 12 US clinical centers.
Pre-assignment Details A total of 247 of the 264 randomized participants who met the inclusion and exclusion criteria received treatment in the study.
Arm/Group Title 0.5% Ivermectin Placebo (Vehicle Control)
Hide Arm/Group Description Participants received a single application of Ivermectin cream on Day 1. Participants received a single application of vehicle control cream on Day 1.
Period Title: Overall Study
Started 192 55
Completed 185 54
Not Completed 7 1
Reason Not Completed
Lost to Follow-up             7             1
Arm/Group Title 0.5% Ivermectin Placebo (Vehicle Control) Total
Hide Arm/Group Description Participants received a single application of Ivermectin cream on Day 1. Participants received a single application of vehicle control cream on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 192 55 247
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 55 participants 247 participants
<=18 years
147
  76.6%
35
  63.6%
182
  73.7%
Between 18 and 65 years
45
  23.4%
20
  36.4%
65
  26.3%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 192 participants 55 participants 247 participants
15.9  (12.9) 19.6  (14.4) 16.76  (13.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 55 participants 247 participants
Female
161
  83.9%
42
  76.4%
203
  82.2%
Male
31
  16.1%
13
  23.6%
44
  17.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 192 participants 55 participants 247 participants
192 55 247
1.Primary Outcome
Title Percentage of Participants With Treatment Success Following Treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.
Time Frame Days 2 up to Day 15 post-treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.5% Ivermectin Placebo (Vehicle Control)
Hide Arm/Group Description:
Participants received a single application of Ivermectin cream on Day 1.
Participants received a single application of vehicle control cream on Day 1.
Overall Number of Participants Analyzed 192 55
Measure Type: Number
Unit of Measure: Percent of Participants
Day 2 (N = 192, 55) 95 53
Day 8 (N = 191, 55) 83 49
Day 15 (N = 185, 54) 76 35
2.Primary Outcome
Title Number of Participants Reporting Adverse Events Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description [Not Specified]
Time Frame Day 1 up to Day 28 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Adverse events were assessed in the Intent-to-treat (Safety) population.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin cream on Day 1.
Participants received a single application of vehicle control cream on Day 1.
Overall Number of Participants Analyzed 192 55
Measure Type: Number
Unit of Measure: Participants
Conjunctivitis 1 0
Application site pruritus 1 1
Influenza 2 0
Nail bed infection 1 0
Pharyngitis 1 0
Pyoderma 1 0
Swine influenza 1 0
Upper respiratory tract infection 5 0
Contusion 1 0
Excoriation 8 4
Scratch 1 0
Headache 1 0
Asthma 1 0
Dyspnoea 1 0
Oropharyngeal pain 2 0
Erythema 2 1
Pruritus 4 0
Rash maculo-papular 1 0
3.Primary Outcome
Title Summary of the Reported Skin/Scalp Irritations Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description

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.
Time Frame Day 1 up to Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Local tolerability was assessed in the Intent-to-treat (Safety) population.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description:
Participants received a single application of 0.5% ivermectin cream on Day 1.
Participants received a single application of vehicle control cream on Day 1.
Overall Number of Participants Analyzed 192 55
Measure Type: Number
Unit of Measure: Participants
Any Erythema Day 1 (Pre-treatment; N = 192, 55) 26 5
Severe Erythema Day 1 (Pre-treatment; N = 192, 55) 0 0
Any Erythema Day 2 (N = 192, 55) 18 3
Severe Erythema Day 2 (N = 192, 55) 0 0
Any Erythema Day 8 (N = 181, 29) 7 0
Severe Erythema Day 8 (N = 181, 29) 0 0
Any Erythema Day 15 (N = 152, 26) 3 0
Severe Erythema Day 15 (N = 152, 26) 0 0
Any Excoriation Day 1 (Pre-treatment; N = 192, 55) 31 7
Severe Excoriation Day 1 (Pre-treatment; N=192, 55 0 0
Any Excoriation Day 2 (N = 192, 55) 27 7
Severe Excoriation Day 2 (N = 192, 55) 0 0
Any Excoriation Day 8 (N = 181, 29) 15 2
Severe Excoriation Day 8 (N = 181, 29) 0 0
Any Excoriation Day 15 (N = 152, 26) 4 0
Severe Excoriation Day 15 (N = 152, 26) 0 0
Any Pruritus Day 1 (Pre-treatment; N = 192, 55) 134 36
Severe Pruritus Day 1 (Pre-treatment; N = 192, 55) 17 3
Any Pruritus Day 2 (N = 192, 55) 56 25
Severe Pruritus Day 2 (N = 192, 55) 0 0
Any Pruritus Day 8 (N = 181, 29) 32 5
Severe Pruritus Day 8 (N = 181, 29) 0 0
Any Pruritus Day 15 (N = 152, 26) 8 2
Severe Pruritus Day 15 (N = 152, 26) 0 0
Any Pyoderma Day 1 (Pre-treatment, N = 192, 55) 1 1
Severe Pyoderma Day 1 (Pre-treatment; N = 192, 55) 0 0
Any Pyoderma Day 2 (N = 192, 55) 1 1
Severe Pyoderma Day 2 (N = 192, 55) 0 0
Any Pyoderma Day 8 (N = 181, 29) 1 0
Severe Pyoderma Day 8 (N = 181, 29) 0 0
Any Pyoderma Day 15 (N = 152, 26) 0 0
Severe Pyoderma Day 15 (N = 152, 26) 0 0
Time Frame Adverse event data were collected form Day 1 up to Day 28 post-treatment with either Ivermectin or Placebo
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5% Ivermectin Placebo (Vehicle Control)
Hide Arm/Group Description Participants received a single application of Ivermectin cream on Day 1. Participants received a single application of vehicle control cream on Day 1.
All-Cause Mortality
0.5% Ivermectin Placebo (Vehicle Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0.5% Ivermectin Placebo (Vehicle Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/192 (0.00%)   0/55 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
0.5% Ivermectin Placebo (Vehicle Control)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/192 (4.17%)   4/55 (7.27%) 
Injury, poisoning and procedural complications     
Excoriation * 1  8/192 (4.17%)  4/55 (7.27%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Sanofi Topaz
EMail: RegistryContactUs@sanofipasteur.com
Layout table for additonal information
Responsible Party: Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT00994422     History of Changes
Other Study ID Numbers: TOP010
First Submitted: October 9, 2009
First Posted: October 14, 2009
Results First Submitted: March 7, 2012
Results First Posted: April 4, 2012
Last Update Posted: April 6, 2012