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A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation (LICE OUT)

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ClinicalTrials.gov Identifier: NCT01066585
Recruitment Status : Completed
First Posted : February 10, 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: Ivermectin Cream
Drug: vehicle control
Enrollment 410
Recruitment Details Participants were enrolled and treated from 8 March 2010 to 9 June 2010 in 8 US clinical centers.
Pre-assignment Details A total of 410 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 211 199
Completed 210 196
Not Completed 1 3
Reason Not Completed
Protocol Violation             1             0
Withdrawal by Subject             0             3
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 211 199 410
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 199 participants 410 participants
<=18 years
164
  77.7%
149
  74.9%
313
  76.3%
Between 18 and 65 years
47
  22.3%
50
  25.1%
97
  23.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 211 participants 199 participants 410 participants
13.92  (12.00) 15.05  (13.52) 14.47  (12.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 211 participants 199 participants 410 participants
Female
172
  81.5%
164
  82.4%
336
  82.0%
Male
39
  18.5%
35
  17.6%
74
  18.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 211 participants 199 participants 410 participants
211 199 410
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 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.
Time Frame Day 2 up to Day 15 post-application
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 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 71 74
Measure Type: Number
Unit of Measure: Percent of Participants
Day 15 (LOCF Imputation) 76 16
Day 15 (Treatment Failure Imputation) 76 15
2.Secondary 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
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 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 211 199
Measure Type: Number
Unit of Measure: Percent of Participants
Day 15 (LOCF Imputation) 82 22
Day 15 (Treatment Failure Imputation) 81 21
3.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description

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.

Time Frame Day 1 up to Day 15 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 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 210 199
Measure Type: Number
Unit of Measure: Participants
Any Lymphadenopathy 0 1
Severe Lymphadenopathy 0 0
Any Eye Irritation 1 0
Severe Eye Irritation 0 0
Any Impetigo 0 1
Severe Impetigo 0 0
Any Pharyngitis Streptococcal 1 0
Severe Pharyngitis Streptococcal 0 0
Any Tonsillitis 1 0
Severe Tonsillitis 0 0
Any Excoriation 0 4
Severe Excoriation 0 0
Any Cough 1 0
Severe Cough 0 0
Any Erythema 0 2
Severe Erythema 0 0
Any Pruritis 3 4
Severe Pruritus 0 0
Any Skin Burning Sensation 1 0
Severe Skin Burning Sensation 0 0
4.Secondary Outcome
Title Summary of the Reported Skin/Scalp Irritation Before Treatment 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 1 up to Day 15 post-application
Hide 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 211 199
Measure Type: Number
Unit of Measure: Participants
Any Pruritus Day 1 (Pre-treatment; N = 211, 199) 126 136
Severe Puritus Day 1 (Pre-treatment; N = 211, 199) 7 10
Any Pruritus Day 2 (N = 210, 199) 41 98
Severe Pruritus Day 2 (N = 210, 199) 2 7
Any Pruritus Day 8 (N = 203, 77) 31 10
Severe Pruritus Day 8 (N = 203, 77) 0 0
Any Pruritus Day 15 (N = 197, 51) 12 3
Severe Pruritus Day 15 (N = 197, 51) 0 0
Any Erythema Day 1 (Pre-treatment; N = 211, 199) 16 23
Severe Erythema Day 1 (Pre-treatment; N= 211, 199) 0 1
Any Erythema Day 2 (N = 210, 199) 14 22
Severe Erythema Day 2 (N = 210, 199) 0 0
Any Erythema Day 8 (N = 203, 77) 8 2
Severe Erythema Day 8 (N = 203, 77) 0 0
Any Erythema Day 15 (N = 197, 51) 2 0
Severe Erythema Day 15 (N = 197, 51) 0 0
Any Excoriation Day 1 (Pre-treatment; N= 211, 199) 16 48
Severe Excoriation Day 1 (Pre-treatment; N=211,199 0 0
Any Excoriation Day 2 (N = 210, 199) 14 34
Severe Excoriation Day 2 (N = 210, 199) 0 0
Any Excoriation Day 8 (N = 203, 77) 3 8
Severe Excoriation Day 8 (N = 203, 77) 0 0
Any Excoriation Day 15 (N = 197, 51) 1 2
Severe Excoriation Day 15 (N = 197, 51) 0 0
Any Pyoderma Day 1 (Pre-treatment; N = 211, 199) 0 3
Severe Pyoderma Day 1 (Pre-treatment; N= 211, 199) 0 0
Any Pyoderma Day 2 (N = 210, 199) 0 3
Severe Pyoderma Day 2 (N = 210, 199) 0 0
Any Pyoderma Day 8 (N = 203, 77) 0 1
Severe Pyoderma Day 8 (N = 203, 77) 0 0
Any Pyoderma Day 15 (N = 197, 51) 0 0
Severe Pyoderma Day 15 (N = 197, 51) 0 0
Time Frame Adverse event data were collected from the day of application (Day 1) through Day 15 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   0/210 (0.00%)   0/199 (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   0/210 (0.00%)   0/199 (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: NCT01066585     History of Changes
Other Study ID Numbers: TOP011
First Submitted: February 8, 2010
First Posted: February 10, 2010
Results First Submitted: March 7, 2012
Results First Posted: April 4, 2012
Last Update Posted: April 6, 2012