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A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects (LICE OUT)

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ClinicalTrials.gov Identifier: NCT01068158
Recruitment Status : Completed
First Posted : February 12, 2010
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: 0.5% Ivermectin Cream
Drug: Placebo control
Enrollment 371
Recruitment Details Participants were enrolled and treated from 4 March 2010 to 17 June 2010 in 8 US clinical centers.
Pre-assignment Details A total of 371 participants who met the inclusion and exclusion criteria were enrolled and treated.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1. Participants underwent a single treatment with vehicle control cream at home on Day 1.
Period Title: Overall Study
Started 169 202
Completed 161 198
Not Completed 8 4
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             7             0
Protocol Violation             0             2
Arm/Group Title 0.5% Ivermectin Vehicle Control Total
Hide Arm/Group Description Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1. Participants underwent a single treatment with vehicle control cream at home on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 169 202 371
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 202 participants 371 participants
<=18 years
126
  74.6%
150
  74.3%
276
  74.4%
Between 18 and 65 years
42
  24.9%
52
  25.7%
94
  25.3%
>=65 years
1
   0.6%
0
   0.0%
1
   0.3%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 169 participants 202 participants 371 participants
14.37  (13.33) 15.19  (13.85) 14.82  (13.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 169 participants 202 participants 371 participants
Female
136
  80.5%
151
  74.8%
287
  77.4%
Male
33
  19.5%
51
  25.2%
84
  22.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 169 participants 202 participants 371 participants
169 202 371
1.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Day 2 up to Day 15 post-application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description:
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
Participants underwent a single treatment with vehicle control cream at home on Day 1.
Overall Number of Participants Analyzed 70 74
Measure Type: Number
Unit of Measure: Percent of Participants
Day 15 (LOCF Imputation) 71 19
Day 15 (Treatment Failure Imputation) 69 18
2.Primary Outcome
Title 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)
Hide Description 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.
Time Frame Day 2 up to Day 15 post-application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description:
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
Participants underwent a single treatment with vehicle control cream at home on Day 1.
Overall Number of Participants Analyzed 169 202
Measure Type: Number
Unit of Measure: Percent of Participants
Day 15 (LOCF Imputation) 78 23
Day 15 (Treatment Failure Imputation) 72 21
3.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description

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.

Time Frame Day 2 up to Day 15 post-application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description:
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
Participants underwent a single treatment with vehicle control cream at home on Day 1.
Overall Number of Participants Analyzed 169 202
Measure Type: Number
Unit of Measure: Participants
Any Conjunctivitis 1 0
Severe Conjunctivitis 0 0
Any Ocular Hyperemia 1 1
Severe Ocular Hyperemia 0 0
Any Toothache 1 0
Severe Toothache 0 0
Any Vomiting 0 1
Severe Vomiting 0 0
Any Pyrexia 0 1
Severe Pyrexia 0 0
Any Otitis Media 0 1
Severe Otitis Media 0 0
Any Excoriation 1 1
Severe Excoriation 0 0
Any Injury 0 1
Severe Injury 0 0
Any Scratch 0 1
Severe Scratch 0 0
Any Musculoskeletal Pain 0 1
Severe Musculoskeletal Pain 0 0
Any Pain in Extremity 0 1
Severe Pain in Extremity 0 0
Any Cough 1 0
Severe Cough 0 0
Any Dandruff 1 0
Severe Dandruff 0 0
Any Dry Skin 1 0
Severe Dry Skin 0 0
Any Erythema 2 3
Severe Erythema 0 0
Any Pruritus 0 2
Severe Pruritus 0 0
4.Secondary Outcome
Title Summary of the Reported Skin/Scalp Irritation Before and Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description

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.

Time Frame Day 2 up to Day 15 post-application
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Skin/scalp irritation was assessed in the Intent-to-Treat (Safety) population.
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description:
Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
Participants underwent a single treatment with vehicle control cream at home on Day 1.
Overall Number of Participants Analyzed 169 202
Measure Type: Number
Unit of Measure: Participants
Any Pruritus Day 1 (Pre-treatment; N = 169, 202) 124 147
Severe Pruritus Day 1 (Pre-treatment; N= 169, 202) 12 8
Any Pruritus Day 2 (N = 166, 200) 55 104
Severe Pruritus Day 2 (N = 166, 200) 1 2
Any Pruritus Day 8 (N = 148, 58) 19 14
Severe Pruritus Day 8 (N = 148, 58) 0 0
Any Pruritus Day 15 (N = 142, 53) 13 8
Severe Pruritus Day 15 (N = 142, 53) 0 0
Erythema Day 1 (Pre-treatment; N = 169, 202) 45 53
Severe Erythema Day 1 (Pre-treatment; N= 169, 202) 0 0
Any Erythema Day 2 (N = 166, 200) 31 41
Severe Erythema Day 2 (N = 166, 200) 0 0
Any Erythema Day 8 (N = 148, 58) 8 1
Severe Erythema Day 8 (N = 148, 58) 0 0
Any Erythema Day 15 (N = 142, 53) 4 0
Severe Erythema Day 15 (N = 142, 53) 0 0
Any Excoriation Day 1 (Pre-treatment; N= 169, 202) 42 46
Severe Excoriation Day 1 (Pre-treatment N=169, 202 0 1
Any Excoriation Day 2 (N = 166, 200) 36 46
Severe Excoriation Day 2 (N = 166, 200) 0 1
Any Excoriation Day 8 (N = 148, 58) 13 5
Severe Excoriation Day 8 (N = 148, 58) 0 0
Any Excoriation Day 15 (N = 142, 53) 5 4
Severe Excoriation Day 15 (N = 142, 53) 0 0
Any Pyoderma Day 1 (Pre-treatment; N= 169, 202) 3 2
Severe Pyoderma Day 1 (Pre-treatment; N= 169, 202) 0 0
Any Pyoderma Day 2 (N = 166, 200) 3 2
Severe Pyoderma Day 2 (N = 166, 200) 0 0
Any Pyoderma Day 8 (N = 148, 58) 1 1
Severe Pyoderma Day 8 (N = 148, 58) 0 0
Any Pyoderma Day 15 (N = 142, 53) 2 1
Severe Pyoderma Day 15 (N = 142, 53) 0 0
Time Frame Adverse event data were collected from the day of application (Day 1) through Day 28 post-application.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5% Ivermectin Vehicle Control
Hide Arm/Group Description Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1. Participants underwent a single treatment with vehicle control cream at home on Day 1.
All-Cause Mortality
0.5% Ivermectin Vehicle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
0.5% Ivermectin Vehicle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/169 (0.00%)   0/202 (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 Vehicle Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/169 (0.00%)   0/202 (0.00%) 
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
Name/Title: Medical Director
Organization: Sanofi Topaz
Responsible Party: Topaz Pharmaceuticals Inc
ClinicalTrials.gov Identifier: NCT01068158     History of Changes
Other Study ID Numbers: TOP012
First Submitted: February 11, 2010
First Posted: February 12, 2010
Results First Submitted: March 7, 2012
Results First Posted: April 4, 2012
Last Update Posted: April 6, 2012