A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation

NCT02010333 | Completed Phase 2

• 1 other identifier: Ha03-003
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Head Lice Infestation

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Study Arms (1)

Ha44 Gel 0.74% w/w

EXPERIMENTAL

Open label, one arm

Drug: Ha44 Gel 0.74% w/w

Interventions

Ha44 Gel 0.74% w/w DRUG

HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.

Also known as: Abametapir 0.74%, Benzyl Alcohol

Ha44 Gel 0.74% w/w

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

Study Sites (2)

Universal Biopharma Research Institute

Dinuba, California, 93618, United States

Location

Axis Clinical Trials

Los Angeles, California, 90036, United States

Location

MeSH Terms

Interventions

Benzyl Alcohol

Intervention Hierarchy (Ancestors)

Benzyl Alcohols; Alcohols; Organic Chemicals; Benzyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

US (2)