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Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for 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: NCT01907490
Recruitment Status : Completed
First Posted : July 25, 2013
Results First Posted : February 9, 2015
Last Update Posted : April 26, 2017
Sponsor:
Collaborators:
Accelovance
Target Health Inc.
Information provided by (Responsible Party):
Hatchtech Pty Ltd

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Head Lice Infestation
Intervention Drug: Ha44 Gel
Enrollment 38
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ha44 Gel 0.74% w/w
Hide Arm/Group Description Ha44 Gel 0.74% w/w Open label, one arm
Period Title: Overall Study
Started 38
Completed 38
Not Completed 0
Arm/Group Title Ha44 Gel 0.74% w/w
Hide Arm/Group Description Ha44 Gel 0.74% w/w Open label, one arm
Overall Number of Baseline Participants 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 38 participants
6months-<12 months 8
12 months- <2 years 9
2 years - <3 years 11
3years-<18 years 10
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants
Female
20
  52.6%
Male
18
  47.4%
1.Primary Outcome
Title Number of the Subjects With AEs.
Hide Description Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
paediatric population, children between ages 6 months to <18 years.
Arm/Group Title Ha44 Gel 0.74% w/w
Hide Arm/Group Description:
Ha44 Gel 0.74% w/w Open label, one arm
Overall Number of Participants Analyzed 38
Measure Type: Number
Unit of Measure: participants
8
2.Secondary Outcome
Title Pk Parameters: Cmax
Hide Description Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
Time Frame 3 months
Outcome Measure Data Not Reported
3.Secondary Outcome
Title PK Parameters: Tmax
Hide Description Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
Time Frame 3 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title PK Parameters: AUC
Hide Description Pharmacokinetics of Ha44 and Benzyl Alcohol evaluation
Time Frame 3 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ha44 Gel 0.74% w/w
Hide Arm/Group Description Ha44 Gel 0.74% w/w Open label, one arm
All-Cause Mortality
Ha44 Gel 0.74% w/w
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ha44 Gel 0.74% w/w
Affected / at Risk (%)
Total   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ha44 Gel 0.74% w/w
Affected / at Risk (%)
Total   2/38 (5.26%) 
Skin and subcutaneous tissue disorders   
Dermatitis contact  2/38 (5.26%) 
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.
For any publication or presentation the materials will be provided to the sponsor for approval. Sponsor will be permitted of 90-120 days for a review and shall have right to request modification if the material to be published will jeopardize the intellectual property of the sponsor .
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: NCT01907490     History of Changes
Other Study ID Numbers: Ha03-004
First Submitted: July 22, 2013
First Posted: July 25, 2013
Results First Submitted: January 12, 2015
Results First Posted: February 9, 2015
Last Update Posted: April 26, 2017