Trial | NCT00244439  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    permethrin malathion ...

  • Study Participants

    360
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.
Study Started
Dec 31
2005
Primary Completion
Oct 31
2006
Study Completion
Dec 31
2006
Last Update
Dec 23
2013
Estimate

Drug MALG

30 minute application

Drug Ovide (malathion) lotion 0.05%

8-12 hour application

Drug Permethrin 1%

10 minute application

3 Active Comparator

Permethrin 1%

1 Experimental

MALG

2 Active Comparator

Ovide

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
No Results Posted