Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
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
1 other identifier
interventional
360
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2005
Shorter than P25 for phase_3
6 active sites
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
First Submitted
Initial submission to the registry
October 24, 2005
CompletedFirst Posted
Study publicly available on registry
October 26, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedDecember 23, 2013
November 1, 2013
10 months
October 24, 2005
December 19, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure of Head Lice
4 weeks
Secondary Outcomes (1)
Safety of treatments
4 weeks
Study Arms (3)
1
EXPERIMENTALMALG
2
ACTIVE COMPARATOROvide
3
ACTIVE COMPARATORPermethrin 1%
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Investigator Site
Scottsdale, Arizona, United States
Investigator Site
Miami, Florida, United States
Investigator Site
St. Petersburg, Florida, United States
Investigator Site
West Palm Beach, Florida, United States
Investigator Site
New York, New York, United States
Investigator Site
Miamiville, Ohio, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 24, 2005
First Posted
October 26, 2005
Study Start
December 1, 2005
Primary Completion
October 1, 2006
Study Completion
December 1, 2006
Last Updated
December 23, 2013
Record last verified: 2013-11