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: Permethrin 1% rinse; Drug: Malathion gel 0.5%

• Registration Number: NCT00927472
• 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 First Submitted: 2009-06-23
• Study First Submitted QC: 2009-06-24
• Study First Posted: 2009-06-25
• Study Start: 2009-08
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Results First Submitted: 2014-01-17
• Status Verified: 2014-07
• Results First Submitted QC: 2014-07-09
• Last Update Submitted: 2014-07-09
• Results First Posted: 2014-08-04
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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
Nix Creme Rinse	Permethrin 1% rinse	Nix applied to scalp for 10 minutes
Malathion Gel	Malathion gel 0.5%	Malathion gel 0.5% 30 minute application

Primary Outcome Measures

Name	Time	Method
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF)	3 weeks	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
Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF).	3 weeks	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
Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment	3 weeks	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).
Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment	3 weeks	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.
Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment.	3 weeks	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))

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigator Site; 🇺🇸 Jonesboro, Arkansas, United States