NCT00291057

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 23, 2013

Status Verified

November 1, 2013

Enrollment Period

8 months

First QC Date

February 10, 2006

Last Update Submit

December 19, 2013

Conditions

Lice Infestations

Keywords

PediculosisHead Lice

Outcome Measures

Primary Outcomes (1)

  • Change in cholinesterase level

    1 day

Secondary Outcomes (3)

  • Clinical evidence of cholinesterase inhibition

    1 day

  • Local tolerability

    1 day

  • Cure of head lice 14 days after last treatment

    2 weeks

Study Arms (1)

1

EXPERIMENTAL

MALG

Drug: MALG

Interventions

MALGDRUG

30 minute application

1

Eligibility Criteria

Age6 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Confirmed active head lice infestation
  • Parent or guardian must be able to apply treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigator Site

Scottsdale, Arizona, United States

Location

Investigator Site

St. Petersburg, Florida, United States

Location

Investigator Site

West Palm Beach, Florida, United States

Location

Investigator Site

New York, New York, United States

Location

Investigator Site

Miamiville, Ohio, United States

Location

MeSH Terms

Conditions

Lice Infestations

Condition Hierarchy (Ancestors)

Ectoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

February 1, 2006

Primary Completion

October 1, 2006

Study Completion

December 1, 2006

Last Updated

December 23, 2013

Record last verified: 2013-11

Locations

US(5)