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Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

Primary Purpose

Lice Infestations

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MALG
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 Pediculosis, Head Lice

Eligibility Criteria

6 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed active head lice infestation Parent or guardian must be able to apply treatment Exclusion Criteria: Allergy to pediculicides or hair care products Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Current antibiotic treatment

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

MALG

Outcomes

Primary Outcome Measures

Change in cholinesterase level

Secondary Outcome Measures

Clinical evidence of cholinesterase inhibition
Local tolerability
Cure of head lice 14 days after last treatment

Full Information

First Posted
February 10, 2006
Last Updated
December 19, 2013
Sponsor
Taro Pharmaceuticals USA
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1. Study Identification

Unique Protocol Identification Number
NCT00291057
Brief Title
Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
Official Title
Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
February 2006 (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
In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
MALG
Intervention Type
Drug
Intervention Name(s)
MALG
Intervention Description
30 minute application
Primary Outcome Measure Information:
Title
Change in cholinesterase level
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Clinical evidence of cholinesterase inhibition
Time Frame
1 day
Title
Local tolerability
Time Frame
1 day
Title
Cure of head lice 14 days after last treatment
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed active head lice infestation Parent or guardian must be able to apply treatment Exclusion Criteria: Allergy to pediculicides or hair care products Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Current antibiotic treatment
Facility Information:
Facility Name
Investigator Site
City
Scottsdale
State/Province
Arizona
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

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Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

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