Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

Taro Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Lice Infestations

Treatments: Drug: MALG; Drug: Ovide (malathion) lotion 0.05%; Drug: Permethrin 1%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00244439

MALG-0506

Details and patient eligibility

About

Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Enrollment: 360 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed active head lice infestation
• Patient, parent or guardian must be able to apply the treatment
• Entire household must be screened
• All infested persons must agree to participate

Exclusion criteria

• Allergy to pediculicides, hair care products or chrysanthemums
• Scalp conditions other than head lice
• Previous head lice treatment within the past 4 weeks
• Female patients who are pregnant or nursing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

1

Experimental group

Description:

MALG

Treatment:

Drug: MALG

2

Active Comparator group

Description:

Ovide

Treatment:

Drug: Ovide (malathion) lotion 0.05%

3

Active Comparator group

Description:

Permethrin 1%

Treatment:

Drug: Permethrin 1%