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An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01336647
Recruitment Status : Completed
First Posted : April 18, 2011
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Hatchtech Pty Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pediculosis
Interventions Drug: Group A - Low-Dose Ha44 0.37% w/w
Drug: Group B - High Dose Ha44 Gel 0.74% w/w
Drug: Group C - Placebo
Enrollment 142
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Ha 44 Gel High-Dose Ha44 Vehicle
Hide Arm/Group Description Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose. High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
Period Title: Overall Study
Started 46 49 47
Completed 42 48 44
Not Completed 4 1 3
Reason Not Completed
Lost to Follow-up             4             1             3
Arm/Group Title Low Dose Ha44 Gel High-Dose Ha44 Vehicle Total
Hide Arm/Group Description Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes Vehicle Gel without active ingredient of Ha44. Total of all reporting groups
Overall Number of Baseline Participants 46 49 47 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 49 participants 47 participants 142 participants
<=18 years
38
  82.6%
35
  71.4%
30
  63.8%
103
  72.5%
Between 18 and 65 years
8
  17.4%
14
  28.6%
17
  36.2%
39
  27.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 49 participants 47 participants 142 participants
13.7  (10.5) 15.3  (11.3) 17.3  (13.3) 15.4  (11.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 49 participants 47 participants 142 participants
Female
42
  91.3%
42
  85.7%
44
  93.6%
128
  90.1%
Male
4
   8.7%
7
  14.3%
3
   6.4%
14
   9.9%
1.Primary Outcome
Title Number of Participants Who Are Lice Free at All Follow-up Visits (Day 1, 7 and 14) Through the Day 14 Visit
Hide Description [Not Specified]
Time Frame Follow up visit at days 1, 7 and 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat
Arm/Group Title Low Dose Ha44 Hig Dose Ha44 Vehicle
Hide Arm/Group Description:
Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.
Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
Overall Number of Participants Analyzed 46 49 47
Measure Type: Number
Unit of Measure: participants
31 42 11
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose Ha44, Hig Dose Ha44, Vehicle
Comments Null hypothesis; 80% power and 0.025 two-sided level of significance for each pairwise active vs. vehicle comparison
Type of Statistical Test Non-Inferiority or Equivalence
Comments The primary efficacy endpoint was responder rate calculated based on the percentage of subjects who were lice free at all follow-up visits (Days 1, 7 and 14). Because the number of responders and non-responders in the family size>= 5 household members was less than five in at least one of the treatment arms, (Table 14.2.1.5), Fisher’s Exact test was used to compare treatment arms, instead of the CMH test.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments The assessment of statistical significance will be done using Hochberg’s modified Bonferroni test.
2.Secondary Outcome
Title Safety and Tolerability of Ha44 Gel
Hide Description The number of subjects with Treatment emergent AEs (TEAEs) related to the study medication will be reported by treatment group.
Time Frame From treatment to last visit of the study at 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who participated
Arm/Group Title Low Dose Ha44 High Dose Ha44 Vehicle
Hide Arm/Group Description:
Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
High-Dose Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
Overall Number of Participants Analyzed 46 49 47
Measure Type: Number
Unit of Measure: participants with treatment related AEs
5 8 13
Time Frame 14 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low Dose Ha44 Gel High Dose Ha44 Gel Vehicle
Hide Arm/Group Description Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes. High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes. Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
All-Cause Mortality
Low Dose Ha44 Gel High Dose Ha44 Gel Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose Ha44 Gel High Dose Ha44 Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/46 (0.00%)      0/49 (0.00%)      0/47 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Low Dose Ha44 Gel High Dose Ha44 Gel Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/46 (23.91%)      2/49 (4.08%)      20/47 (42.55%)    
Skin and subcutaneous tissue disorders       
pruritus  1  8/46 (17.39%)  8 2/49 (4.08%)  2 18/47 (38.30%)  18
Erythema  1  3/46 (6.52%)  3 0/49 (0.00%)  0 2/47 (4.26%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.1)
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.
Results Point of Contact
Name/Title: Clinical Manager
Organization: Hatchtech Pty Ltd
Phone: +61 3 9092 0490
Responsible Party: Hatchtech Pty Ltd
ClinicalTrials.gov Identifier: NCT01336647     History of Changes
Other Study ID Numbers: Ha02-003
First Submitted: April 14, 2011
First Posted: April 18, 2011
Results First Submitted: December 4, 2013
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015