Back to resultsA Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
Primary Purpose
Head Lice Infestation
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ha44 Gel 0.74% w/w
Sponsored by
About this trial
This is an interventional treatment trial for Head Lice Infestation
Eligibility Criteria
Inclusion Criteria:
- Male or female, 6months < 3years of age
- Good health
- Active head lice infestation defined as the presence of at least 3 live lice
- Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
- Parent/guardian agrees to allow PK samples collected
- Signed Informed Consent Form
Exclusion Criteria:
- Condition or illness that in the opinion of the investigator may interfere with the study results.
- Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
- Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
- Receiving systemic or topical medication that may interfere the study results.
- Received an investigational agent within 30 days prior to Day 0.
Sites / Locations
- Universal Biopharma Research Institute
- Axis Clinical Trials
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ha44 Gel 0.74% w/w
Arm Description
Open label, one arm
Outcomes
Primary Outcome Measures
Safety and tolerability of Ha44 Gel
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
Secondary Outcome Measures
Full Information
NCT ID
NCT02010333
First Posted
December 9, 2013
Last Updated
May 6, 2020
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT02010333
Brief Title
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
Official Title
A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
5. Study Description
Brief Summary
The primary purpose of the study is to evaluate safety and tolerability of a single application of Ha44 Gel 0.74% w/w for the treatment of head lice. Secondary purpose is to evaluate PK of Ha44 and benzyl alcohol under conditions of maximal exposure in pediatric population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice Infestation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ha44 Gel 0.74% w/w
Arm Type
Experimental
Arm Description
Open label, one arm
Intervention Type
Drug
Intervention Name(s)
Ha44 Gel 0.74% w/w
Other Intervention Name(s)
Abametapir 0.74%, Benzyl Alcohol
Intervention Description
HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.
Primary Outcome Measure Information:
Title
Safety and tolerability of Ha44 Gel
Description
Clinically significant changes in Physical Examinations, vital signs, safety laboratory tests and assessments of scalp and eye irritation and Electrocardiogram. The frequency and severity of Adverse Events.
Time Frame
8 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, 6months < 3years of age
Good health
Active head lice infestation defined as the presence of at least 3 live lice
Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)
Parent/guardian agrees to allow PK samples collected
Signed Informed Consent Form
Exclusion Criteria:
Condition or illness that in the opinion of the investigator may interfere with the study results.
Current dermatological disease that may compromise the health of subject or the assessment of safety. Subjects with scalp ulceration or evidence of scalp infection should not be enrolled.
Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
Receiving systemic or topical medication that may interfere the study results.
Received an investigational agent within 30 days prior to Day 0.
Facility Information:
Facility Name
Universal Biopharma Research Institute
City
Dinuba
State/Province
California
ZIP/Postal Code
93618
Country
United States
Facility Name
Axis Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
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