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

Phase 3

Completed

• Conditions: Pediculosis
• Interventions: Drug: Malathion gel 0.5%; Drug: Permethrin 1% rinse (Nix Crème)

• Registration Number: NCT00963508
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-14
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2014-01-31
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-14
• Last Update Submitted: 2014-05-14
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Malathion Gel	Malathion gel 0.5%	Malathion gel 0.5% 30 minute application
Nix Crème Rinse	Permethrin 1% rinse (Nix Crème)	Nix Crème Rinse applied to scalp for 10 minutes

Primary Outcome Measures

Name	Time	Method
Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)	3 weeks	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))

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).	3 weeks	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)

Trial Locations

Locations (1)

Investigator Site; 🇺🇸 San Antonio, Texas, United States