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

Sun Pharmaceutical Industries, Inc.360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

360

Conditions

Lice Infestations

Interventions

MALGDRUG

30 minute application

Ovide (malathion) lotion 0.05%DRUG

8-12 hour application

Permethrin 1%DRUG

10 minute application

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (6)

Investigator Site

Scottsdale, Arizona, United States

Investigator Site

Miami, Florida, United States

Investigator Site

St. Petersburg, Florida, United States

Investigator Site

West Palm Beach, Florida, United States

Outcomes

Primary Outcomes

Cure of Head Lice

Time frame: 4 weeks

Secondary Outcomes

Safety of treatments

Time frame: 4 weeks

Data from ClinicalTrials.gov

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