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

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2010

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Malathion Gel
    • Malathion gel 0.5% 30 minute application
  • Active Comparator: Nix Creme Rinse
    • Nix applied to scalp for 10 minutes

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF))
    • Time Frame: 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))
    • Time Frame: 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
    • Time Frame: 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 (LOCF)
    • Time Frame: 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 Modified ITT (Non LOCF)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Taro Pharmaceuticals USA
  • Provider of Information About this Clinical Study
    • Sponsor

References

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 Crème Rinse (1% permethrin) used as labeled, for the treatment of head lice. Pediatr Dermatol. 2007 Jul-Aug;24(4):405-11.

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