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

Taro Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Lice Infestations

Treatments: Drug: MALG

Study type: Interventional

Funder types: Industry

Identifiers

NCT00291057

MALG-0508

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

1

Experimental group

Description:

MALG

Treatment:

Drug: MALG