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An Efficacy and Safety Study of Ha44 Gel Administered Topically for the Treatment of Head Lice Infestation

NCT01336647 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2020-04-29

Study results available
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Summary

Phase 2 study to assess the safety and effectiveness of a product to treat children and adults with head lice

Conditions

  • Pediculosis

Interventions

DRUG

Group A - Low-Dose Ha44 0.37% w/w

Low Dose Ha44 Gel applied to scalp and hair for 10 minutes

DRUG

Group B - High Dose Ha44 Gel 0.74% w/w

High Dose Ha44 Gel applied to scalp and hair for 10 minutes

DRUG

Group C - Placebo

Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Miguel Restrepo · Universal Biopharma Reserach Inc.

  • Lydie Hazan · Axis Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2011-08-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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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 NCT01336647 on ClinicalTrials.gov