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

A Multi-Center Phase III Study to Evaluate Ovide Lotion 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis

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.

Study Overview

• Status: Completed
• Conditions: Pediculosis
• Intervention / Treatment: Drug: Malathion gel 0.5%; Drug: Permethrin 1% rinse

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 Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Bentonville, Arkansas, United States
      • Investigator site
    • Jonesboro, Arkansas, United States
      • Investigator site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Malathion Gel; Malathion gel 0.5% 30 minute application	Drug: Malathion gel 0.5%; Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
Active Comparator: Nix Creme Rinse; Nix applied to scalp for 10 minutes	Drug: Permethrin 1% rinse; Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present.; Other Names: Nix Creme Rinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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))	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).	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.	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	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	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	3 weeks

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Publications and helpful links

General Publications

• Meinking TL, Vicaria M, Eyerdam DH, Villar ME, Reyna S, Suarez G. A randomized, investigator-blinded, time-ranging study of the comparative efficacy of 0.5% malathion gel versus Ovide Lotion (0.5% malathion) or Nix Creme Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11. doi: 10.1111/j.1525-1470.2007.00460.x.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 23, 2009
• First Submitted That Met QC Criteria: June 24, 2009
• First Posted (Estimate): June 25, 2009

Study Record Updates

• Last Update Posted (Estimate): August 4, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Head Lice
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Permethrin; Malathion
• Other Study ID Numbers: MALG-0817