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

Phase 2

Completed

• Conditions: Head Lice Infestation
• Interventions: Drug: Ha44 Gel 0.74% w/w

• Registration Number: NCT02010333
• Lead Sponsor: Dr. Reddy's Laboratories Limited

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Disposition First Submitted: 2015-08-25
• Disposition First Submitted QC: 2015-09-09
• Disposition First Posted: 2015-09-25
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ha44 Gel 0.74% w/w	Ha44 Gel 0.74% w/w	Open label, one arm

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of Ha44 Gel	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.

Trial Locations

Locations (2)

Universal Biopharma Research Institute; 🇺🇸 Dinuba, California, United States

Axis Clinical Trials; 🇺🇸 Los Angeles, California, United States