Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

Taro Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Pediculosis

Treatments: Drug: Malathion gel 0.5%; Drug: Permethrin 1% rinse

Study type: Interventional

Funder types: Industry

Identifiers

NCT00927472

MALG-0817

Details and patient eligibility

About

In this study, Malathion Gel 0.5% will be compared to Nix (permethrin 1%) as a treatment for head lice in patients 2 years of age and older. Malathion Gel 0.5% is a new formulation of an established head lice treatment. The new formulation has been evaluated in 2 previous studies of patients 2 years of age and older.

Full description

This is a Phase III, multi-center, investigator-blinded, two-arm, randomized, parallel group study, evaluating the safety and efficacy of a Malathion Gel, 0.5% formulation, manufactured by Taro. The objective is to show superiority of the novel product to an active control, Nix® Crème Rinse, manufactured by Insight Pharmaceuticals.

Enrollment: 254 patients

Sex: All

Ages: 2+ years 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: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 2 patient groups

Malathion Gel

Experimental group

Description:

Malathion gel 0.5% 30 minute application

Treatment:

Drug: Malathion gel 0.5%

Nix Creme Rinse

Active Comparator group

Description:

Nix applied to scalp for 10 minutes

Treatment:

Drug: Permethrin 1% rinse