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Trial record 26 of 103 for:    IVERMECTIN

Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

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ClinicalTrials.gov Identifier: NCT00857948
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : March 30, 2012
Last Update Posted : March 30, 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 Pediculus Humanus Capitis (Head Lice)
Interventions Drug: ivermectin treatment conditioner
Drug: Placebo, vehicle control
Enrollment 78
Recruitment Details Participants were enrolled and treated on 14 March 2009 in 1 US clinical center.
Pre-assignment Details A total of 78 participants who met the inclusion and exclusion criteria were enrolled and treated.
Arm/Group Title 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Hide Arm/Group Description Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1. Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1. Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1. Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
Period Title: Overall Study
Started 18 18 19 23
Completed 15 18 18 23
Not Completed 3 0 1 0
Reason Not Completed
Withdrawal by Subject             2             0             0             0
Protocol Violation             1             0             1             0
Arm/Group Title 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo Total
Hide Arm/Group Description Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1. Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1. Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1. Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 18 18 19 23 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 19 participants 23 participants 78 participants
<=18 years
16
  88.9%
14
  77.8%
13
  68.4%
21
  91.3%
64
  82.1%
Between 18 and 65 years
2
  11.1%
4
  22.2%
6
  31.6%
2
   8.7%
14
  17.9%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Age Continuous Number Analyzed 18 participants 18 participants 19 participants 23 participants 78 participants
12.28  (13.00) 14.11  (8.71) 14.21  (12.87) 11.13  (8.73) 12.83  (10.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 18 participants 19 participants 23 participants 78 participants
Female
15
  83.3%
15
  83.3%
18
  94.7%
22
  95.7%
70
  89.7%
Male
3
  16.7%
3
  16.7%
1
   5.3%
1
   4.3%
8
  10.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 18 participants 19 participants 23 participants 78 participants
18 18 19 23 78
1.Primary Outcome
Title Percentage of 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 Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Time Frame Day 1 through Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Live lice eradication 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 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Hide Arm/Group Description:
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
Overall Number of Participants Analyzed 18 18 19 23
Measure Type: Number
Unit of Measure: Percent of participants
56 50 74 9
2.Secondary Outcome
Title Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Time Frame Day 1 through Day 8 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
Live lice eradication 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 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Hide Arm/Group Description:
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
Overall Number of Participants Analyzed 18 18 19 23
Measure Type: Number
Unit of Measure: Percent of participants
Day 1: 2 hours post-application 33 44 32 22
Day 1: 6 hours post-application 50 67 58 30
Day 2 83 94 95 17
Day 8 67 72 84 9
3.Secondary Outcome
Title Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control)
Hide Description The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.
Time Frame Day 1 through Day 15 post-application
Hide Outcome Measure Data
Hide Analysis Population Description
The level of lice infestation 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 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Hide Arm/Group Description:
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
Overall Number of Participants Analyzed 18 18 19 23
Measure Type: Number
Unit of Measure: Percent of participants
Day 1: 2 Hours Post Dose: None 33 44 32 22
Day 1: 2 Hours Post Dose: Mild 50 56 63 65
Day 1: 2 Hours Post Dose: Moderate 17 0 5 13
Day 1: 6 Hours Post Dose: None 50 67 58 30
Day 1: 6 Hours Post Dose: Mild 39 33 37 61
Day 1: 6 Hours Post Dose: Moderate 11 0 5 9
Day 2: None 83 94 95 17
Day 2: Mild 17 6 5 78
Day 2: Moderate 0 0 0 4
Day 8: Treatment Failure Day 2 17 6 5 83
Day 8: None 72 72 84 9
Day 8: Mild 11 6 5 9
Day 8: Moderate 0 6 0 0
Day 8: Severe 0 11 5 0
Day 15: Treatment Failure Day 8 33 28 16 91
Day 15: None 56 56 74 9
Day 15: Mild 11 17 11 0
4.Secondary Outcome
Title Number of Participants Reporting Treatment-Emergent 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 assess in the Safety (Intent-to-treat) Population.
Arm/Group Title 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Hide Arm/Group Description:
Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
Overall Number of Participants Analyzed 18 18 19 23
Measure Type: Number
Unit of Measure: Participants
Conjunctivitis 0 0 1 0
Severe Conjunctivitis 0 0 0 0
Eye Pruritus 1 0 0 0
Severe Eye Pruritus 0 0 0 0
Erythema 0 0 1 3
Severe Erythema 0 0 0 0
Folliculitis 0 1 0 1
Severe Folliculitis 0 0 0 0
Pruritus 5 1 3 1
Severe Pruritus 0 0 0 0
Skin Irritation 0 0 0 1
Severe Skin Irritation 0 0 0 0
Time Frame Adverse event data were collected from Day 1 up to Day 28 post-application.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Hide Arm/Group Description Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1. Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1. Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1. Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
All-Cause Mortality
0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/18 (0.00%)      0/18 (0.00%)      0/19 (0.00%)      0/23 (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%
0.15% Ivermectin 0.25% Ivermectin 0.50% Ivermectin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/18 (33.33%)      3/18 (16.67%)      5/19 (26.32%)      5/23 (21.74%)    
Eye disorders         
Conjunctivitis * 1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/19 (5.26%)  1 0/23 (0.00%)  0
Eye Pruritus * 1  1/18 (5.56%)  1 0/18 (0.00%)  0 0/19 (0.00%)  0 0/23 (0.00%)  0
Skin and subcutaneous tissue disorders         
Erythema * 1  0/18 (0.00%)  0 0/18 (0.00%)  0 1/19 (5.26%)  1 3/23 (13.04%)  3
Folliculitis * 1  0/18 (0.00%)  0 1/18 (5.56%)  1 0/19 (0.00%)  0 1/23 (4.35%)  1
Pruritus * 1  5/18 (27.78%)  5 2/18 (11.11%)  2 4/19 (21.05%)  4 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.1
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: NCT00857948     History of Changes
Other Study ID Numbers: TOP003
First Submitted: March 6, 2009
First Posted: March 9, 2009
Results First Submitted: March 1, 2012
Results First Posted: March 30, 2012
Last Update Posted: March 30, 2012