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

NCT01907490 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2020-04-28

Study results available
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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.

Conditions

  • Head Lice Infestation

Interventions

DRUG

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.

Sponsors & Collaborators

  • Accelovance

    collaborator INDUSTRY

  • Target Health Inc.

    collaborator INDUSTRY

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Srinivas Sidgiddi, MD · Dr. Reddy's Laboratories Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2013-07-31
Completion
2013-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907490 on ClinicalTrials.gov