Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

Taro Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pediculosis

Treatments: Drug: MALG (malathion) Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752973

MALG-0813

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: 12 patients

Sex: All

Ages: 6 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed active head lice infestation

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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12 participants in 1 patient group

Treatment arm

Experimental group

Description:

MALG treatment

Treatment:

Drug: MALG (malathion) Treatment