Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice
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.
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Lice Infestations
Intervention
MALG
Location
Scottsdale
Arizona
United States
85251
Status
Terminated
Source
Taro Pharmaceuticals USA
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00291057
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Lice
A general name for small, wingless, parasitic insects, previously of the order Phthiraptera. Though exact taxonomy is still controversial, they can be grouped in the orders ANOPLURA (sucking lice), MALLOPHAGA (biting lice), and Rhynchophthirina (elephant-lice).
Permethrin
A pyrethroid insecticide commonly used in the treatment of LICE INFESTATIONS and SCABIES.
Phthiraptera
An order of small, wingless parasitic insects, commonly known as lice. The suborders include ANOPLURA (sucking lice); AMBLYCERA; ISCHNOCERA; and Rhynchophthirina (elephant and warthog lice).
Lice Infestations
Parasitic attack or subsistence on the skin by members of the order Phthiraptera, especially on humans by Pediculus humanus of the family Pediculidae. The hair of the head, eyelashes, and pubis is a frequent site of infestation. (From Dorland, 28th ed; Stedman, 26th ed)
Mite Infestations
Infestations with arthropods of the subclass ACARI, superorder Acariformes.
Clinical Trials
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
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 nove...
Ivermectin in the Treatment of Head Lice
The purpose of this study is to compare 2 single doses of ivermectin as tablets with 2 single applications of malathion 0.5% lotion (Days 1 and 8) in clearing head lice, in patients who ha...
Control of Head Lice Infestations in Children and Adults
The goal of this study is to see if heated air will kill head lice and their eggs. The treatment visit is approximately 1 hour long with a follow up phone call.
The purpose of this study is to determine if 0.5% Ivermectin Cream is a safe and effective treatment for head lice infestations.
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore cau...
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