Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation

NCT ID: NCT01907490

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-12-31

Brief Summary

The purpose of the study is to evaluate the safety and tolerability of a single application of Ha44 Gel 0.74% w/v for the treatment of head lice under maximal use conditions.

Secondary objective is to evaluate pharmacokinetics of Ha44 and benzyl alcohol (contained in Ha44 vehicle) under maximal use conditions.

Detailed Description

This is an open-label safety and pharmacokinetic (PK) study involving a single application of Ha44 Gel 0.74% administered under maximal use conditions.

All participants must have an active head lice infestation (at least 3 live lice) and be 6 months to 17 years of age. The study will enroll approximately 36 pediatric subjects between the ages of 6 months and 17 years.

Pediatric PK samples will be collected at 0 (predose), 30 and 60 mins and 2 and 8 hrs time points.

More than one household member with an active lice infestation may participate in the study. Eligible subjects will be consented and screened for study eligibility on Day 0 (Visit 1). All subjects will return to the study site for three follow-up clinic visits at Days 1, 7 and 14. The maximum study duration for a subject is 16 days.

Conditions

Head Lice Infestation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Ha44 Gel 0.74%, topical solution, maximum feasible amount applied for 10 minutes

Group Type: EXPERIMENTAL

Ha44 Gel

Intervention Type: DRUG

Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.

Interventions

Ha44 Gel

Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.

Intervention Type: DRUG

Other Intervention Names

Benzyl Alcohol

Eligibility Criteria

Inclusion Criteria

1. Male or female

2. 6 months to 17 years of age

3. Be in good health, as determined by medical history and physical examination

4. Has an active head lice infestation at screening as determined by an experienced evaluator. An active infestation is defined as the presence of at least 3 live lice.

5. Female subjects must be:

• Of non-childbearing potential (no history of menstrual periods, post-hysterectomy, or post-menopausal for at least 2 years) OR,
• If of childbearing potential, must have a negative urine pregnancy test prior to treatment and agree to use a highly effective method of contraception from Day 0 through the Day 14 visit. Acceptable methods of contraception include abstinence, vasectomized partner, tubal ligation, combined oral hormonal contraceptive, contraceptive injection, contraceptive patch, or IUD. If a hormonal contraception is the only method, the subject must have been on a stable dose for at least 3 months.

6. The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.

7. Has signed an informed consent and/or assent form (ICF).

Exclusion Criteria

1. Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.

2. Has current dermatological disease or inflammation on the face, scalp, ears, neck or back, including eczema, atopic dermatitis, alopecia, psoriasis or any other chronic skin disease that, in the opinion of the Investigator, would interfere with the safety or PK evaluation.

3. Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.

4. Has been using hormonal contraception for less than 3 months.

5. Is pregnant or currently nursing.

6. Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.

7. Has received an investigational agent within 30 days prior to Day 0.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Accelovance

INDUSTRY

Sponsor Role: collaborator

Target Health Inc.

INDUSTRY

Sponsor Role: collaborator

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srinivas Sidgiddi, MD

Role: STUDY_DIRECTOR

Dr. Reddy's Laboratories Inc.

Other Identifiers

Ha03-004

Identifier Type: -

Identifier Source: org_study_id