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

Sun Pharmaceutical Industries, Inc.254 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

254

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% rinseDRUG

Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if 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 (2)

Investigator Site

Bentonville, Arkansas, United States

Investigator Site

Jonesboro, Arkansas, United States

Outcomes

Primary Outcomes

Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.

Treatment Success was evaluated using the Efficacy Intention to Treat (eITT) (LOCF) Efficacy ITT (eITT) was considered definitive. 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). Index subject: 95 from 254 randomized (the youngest subject in the household who met index case criteria( having nits and at least 3 live lice))

Time frame: 3 weeks

Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment

Treatment Success in the Efficacy Intention to Treat (eITT) (No 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).

Time frame: 3 weeks

Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment

Treatment Success in the Per Protocol Population (PPP) The PPP included all subjects who complied strictly with the protocol and had outcome data for all required visits. Superiority analysis in the PPP was considered to be supportive.

Time frame: 3 weeks

Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)

Treatment Success in the Modified Intention to Treat (Modified ITT) (LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

Time frame: 3 weeks

Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).

Treatment Success in the Modified ITT (non-LOCF) The Modified ITT included all randomized subjects who were treated and returned for at least one post-treatment visit. Subjects with missing efficacy data were included first with LOCF and then with non-LOCF

Data from ClinicalTrials.gov

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Secondary Outcomes

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

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

Time frame: 3 weeks

Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF))

Treatment Success in the Efficacy ITT (non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment.

Time frame: 3 weeks

Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP

Treatment Success in the PPP The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the PPP was considered supportive.

Time frame: 3 weeks

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

Treatment Success in the Modified ITT (LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the Modified ITT was considered supportive.

Time frame: 3 weeks

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

Treatment Success in the Modified ITT (non LOCF) The secondary efficacy variable was the proportion of index subjects who were lice-free 14 days after their first treatment. The evaluations in the Modified ITT was considered supportive.

Time frame: 3 weeks