- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02010333
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation
May 6, 2020 updated by: Dr. Reddy's Laboratories Limited
A Pediatric Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
22
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Dinuba, California, United States, 93618
- Universal Biopharma Research Institute
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Los Angeles, California, United States, 90036
- Axis Clinical Trials
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 2 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ha44 Gel 0.74% w/w
Open label, one arm
|
HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of Ha44 Gel
Time Frame: 8 months
|
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.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
July 1, 2014
Study Completion (ACTUAL)
August 1, 2014
Study Registration Dates
First Submitted
December 9, 2013
First Submitted That Met QC Criteria
December 9, 2013
First Posted (ESTIMATE)
December 12, 2013
Study Record Updates
Last Update Posted (ACTUAL)
May 12, 2020
Last Update Submitted That Met QC Criteria
May 6, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Infections
- Ectoparasitic Infestations
- Skin Diseases, Parasitic
- Skin Diseases, Infectious
- Lice Infestations
- Parasitic Diseases
- Mite Infestations
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Benzyl Alcohol
Other Study ID Numbers
- Ha03-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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