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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00927472
First received: June 23, 2009
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Pediculosis
Drug: Malathion gel 0.5%
Drug: Permethrin 1% rinse
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:
  • Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment. [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF)) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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.



Enrollment: 254
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Nix Creme 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.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927472

Locations
United States, Arkansas
Investigator Site
Bentonville, Arkansas, United States
Investigator Site
Jonesboro, Arkansas, United States
Sponsors and Collaborators
Taro Pharmaceuticals USA
  More Information

Publications:
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00927472     History of Changes
Other Study ID Numbers: MALG-0817
Study First Received: June 23, 2009
Results First Received: January 17, 2014
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Taro Pharmaceuticals USA:
Head Lice

Additional relevant MeSH terms:
Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Malathion
Permethrin
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014