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Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

Primary Purpose

Lice Infestations

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MALG
Ovide (malathion) lotion 0.05%
Permethrin 1%
Sponsored by
Taro Pharmaceuticals USA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lice Infestations focused on measuring Head Lice, Pediculosis capitis

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed active head lice infestation Patient, parent or guardian must be able to apply the treatment Entire household must be screened All infested persons must agree to participate Exclusion Criteria: Allergy to pediculicides, hair care products or chrysanthemums Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Female patients who are pregnant or nursing

Sites / Locations

  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site
  • Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

MALG

Ovide

Permethrin 1%

Outcomes

Primary Outcome Measures

Cure of Head Lice

Secondary Outcome Measures

Safety of treatments

Full Information

First Posted
October 24, 2005
Last Updated
December 19, 2013
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00244439
Brief Title
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Official Title
A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Taro Pharmaceuticals USA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lice Infestations
Keywords
Head Lice, Pediculosis capitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MALG
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ovide
Arm Title
3
Arm Type
Active Comparator
Arm Description
Permethrin 1%
Intervention Type
Drug
Intervention Name(s)
MALG
Intervention Description
30 minute application
Intervention Type
Drug
Intervention Name(s)
Ovide (malathion) lotion 0.05%
Intervention Description
8-12 hour application
Intervention Type
Drug
Intervention Name(s)
Permethrin 1%
Intervention Description
10 minute application
Primary Outcome Measure Information:
Title
Cure of Head Lice
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Safety of treatments
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed active head lice infestation Patient, parent or guardian must be able to apply the treatment Entire household must be screened All infested persons must agree to participate Exclusion Criteria: Allergy to pediculicides, hair care products or chrysanthemums Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Female patients who are pregnant or nursing
Facility Information:
Facility Name
Investigator Site
City
Scottsdale
State/Province
Arizona
Country
United States
Facility Name
Investigator Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
St. Petersburg
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
West Palm Beach
State/Province
Florida
Country
United States
Facility Name
Investigator Site
City
New York
State/Province
New York
Country
United States
Facility Name
Investigator Site
City
Miamiville
State/Province
Ohio
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

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