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

Head Lice Infestation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02010333
• Other study ID #: Ha03-003
• Status: Completed
• Phase: Phase 2
• Start date: April 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2020
• Source: Dr. Reddy's Laboratories Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 2 Years

Eligibility

Inclusion Criteria:

1. Male or female, 6months < 3years of age

2. Good health

3. Active head lice infestation defined as the presence of at least 3 live lice

4. Dermatological condition of scalp (at least G2 erythema or pruritus with evidence of excoriation/inflammation)

5. Parent/guardian agrees to allow PK samples collected

6. Signed Informed Consent Form

Exclusion Criteria:

1. Condition or illness that in the opinion of the investigator may interfere with the study results.

2. 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.

3. Prior reaction to product containing piperonyl butoxide, pyrethrin, or pyrethrum extract.

4. Receiving systemic or topical medication that may interfere the study results.

5. Received an investigational agent within 30 days prior to Day 0.

Related Conditions & MeSH terms

• Head Lice Infestation
• Lice Infestations
• Parasitic Diseases

Intervention

Drug:
• Ha44 Gel 0.74% w/w
HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.

Locations

Country	Name	City	State
United States	Universal Biopharma Research Institute	Dinuba	California
United States	Axis Clinical Trials	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Reddy's Laboratories Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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