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

Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00291057

Enrollment

Registered

2006-02-13

Start date

2006-02-28

Completion date

2006-12-31

Last updated

2013-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lice Infestations

Keywords

Pediculosis, Head Lice

Brief 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.

Interventions

DRUGMALG

30 minute application

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 24 Months

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

Design outcomes

Primary

Measure	Time frame
Change in cholinesterase level	1 day

Secondary

Measure	Time frame
Clinical evidence of cholinesterase inhibition	1 day
Local tolerability	1 day
Cure of head lice 14 days after last treatment	2 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026