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

Sun Pharmaceutical Industries, Inc.403 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

403

Conditions

Pediculosis

Interventions

Malathion gel 0.5%DRUG

Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.

Permethrin 1% rinse (Nix Crème)DRUG

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

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

Locations (7)

Investigator Site

Hot Springs, Arkansas, United States

Investigator Site

Sacramento, California, United States

Investigator Site

Kissimmee, Florida, United States

Investigator Site

Miami, Florida, United States

Outcomes

Primary Outcomes

Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)

The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7) Treatment Success in the Efficacy ITT (LOCF) index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))

Time frame: 3 weeks

Secondary Outcomes

Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).

The secondary efficacy variable was the proportion of subjects who were considered a Treatment Success 14 days after their first treatment. Treatment Success in the Efficacy ITT (LOCF)

Time frame: 3 weeks

Data from ClinicalTrials.gov

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