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

Phase 2TerminatedNCT00291057

Sun Pharmaceutical Industries, Inc.30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lice Infestations

Interventions

MALGDRUG

30 minute application

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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

Locations (5)

Investigator Site

Scottsdale, Arizona, 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

Outcomes

Primary Outcomes

Change in cholinesterase level

Time frame: 1 day

Secondary Outcomes

Clinical evidence of cholinesterase inhibition

Time frame: 1 day

Local tolerability

Time frame: 1 day

Cure of head lice 14 days after last treatment

Time frame: 2 weeks

Data from ClinicalTrials.gov

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