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

Primary Purpose

Head Lice Infestation

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ha44 Gel

About this trial

This is an interventional treatment trial for Head Lice Infestation focused on measuring Topical treatment of Head Lice Infestation

Eligibility Criteria

6 Months - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female
6 months to 17 years of age
Be in good health, as determined by medical history and physical examination
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.
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.
The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study.
Has signed an informed consent and/or assent form (ICF).

Exclusion Criteria:

Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results.
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.
Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract.
Has been using hormonal contraception for less than 3 months.
Is pregnant or currently nursing.
Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results.
Has received an investigational agent within 30 days prior to Day 0.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Number of the Subjects With AEs.

Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.

Secondary Outcome Measures

Pk Parameters: Cmax

Maximum concentration of Ha44 (Cmax)

PK Parameters: Tmax

Time to maximum concentration of Ha44 (Tmax)

PK Parameters: AUC(0-8)

Area under the concentration-time curve of Ha44 (AUC 0-8)

Full Information

NCT ID

NCT01907490

First Posted

July 22, 2013

Last Updated

April 20, 2020

Sponsor

Dr. Reddy's Laboratories Limited

Collaborators

Accelovance, Target Health Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01907490

Brief Title

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

Official Title

A Safety and Pharmacokinetic Study of Ha44 Gel Administered Topically Under Maximal Use Conditions for the Treatment of Head Lice Infestation.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

July 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Dr. Reddy's Laboratories Limited

Collaborators

Accelovance, Target Health Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Lice Infestation

Keywords

Topical treatment of Head Lice Infestation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ha44 Gel

Other Intervention Name(s)

Benzyl Alcohol

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of the Subjects With AEs.

Description

Safety and tolerability assessed by AEs. Number of subjects with reporting AEs.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Pk Parameters: Cmax

Description

Maximum concentration of Ha44 (Cmax)

Time Frame

0 to 8 hours

Title

PK Parameters: Tmax

Description

Time to maximum concentration of Ha44 (Tmax)

Time Frame

0-8 hours

Title

PK Parameters: AUC(0-8)

Description

Area under the concentration-time curve of Ha44 (AUC 0-8)

Time Frame

0-8 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female 6 months to 17 years of age Be in good health, as determined by medical history and physical examination 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. 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. The parent/guardian agrees to allow serial blood samples collected from subject for PK analysis during study. Has signed an informed consent and/or assent form (ICF). Exclusion Criteria: Has a condition or illness that, in the opinion of the Investigator, may interfere with the study results. 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. Had a prior reaction to products containing piperonyl butoxide, pyrethrin, or pyrethrum extract. Has been using hormonal contraception for less than 3 months. Is pregnant or currently nursing. Receiving systemic or topical medication, which in the opinion of the Investigator, may interfere with the study results. Has received an investigational agent within 30 days prior to Day 0.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Srinivas Sidgiddi, MD

Organizational Affiliation

Dr. Reddy's Laboratories Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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