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Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
This study has been completed.
Sponsor:
Taro Pharmaceuticals USA
Information provided by (Responsible Party):
Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier:
NCT00963508
First received: August 14, 2009
Last updated: May 14, 2014
Last verified: May 2014
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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 (Nix Crème) | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multi-Center Phase III Study to Evaluate Malathion Gel 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 Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) [ Time Frame: 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:
- Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF). [ Time Frame: 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)
| Enrollment: | 403 |
| Study Start Date: | August 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 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 Crème Rinse
Nix Crème Rinse applied to scalp for 10 minutes
|
Drug: Permethrin 1% rinse (Nix Crème)
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.
|
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 (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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: NCT00963508
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963508
Locations
| United States, Arkansas | |
| Investigator Site | |
| Hot Springs, Arkansas, United States | |
| United States, California | |
| Investigator Site | |
| Sacramento, California, United States | |
| United States, Florida | |
| Investigator Site | |
| Kissimmee, Florida, United States | |
| Investigator Site | |
| Miami, Florida, United States | |
| Investigator Site | |
| Ormond Beach, Florida, United States | |
| United States, Mississippi | |
| Investigator Site | |
| Picayune, Mississippi, United States | |
| United States, Texas | |
| Investigator Site | |
| San Antonio, Texas, United States | |
Sponsors and Collaborators
Taro Pharmaceuticals USA
More Information
Publications:
| Responsible Party: | Taro Pharmaceuticals USA |
| ClinicalTrials.gov Identifier: | NCT00963508 History of Changes |
| Other Study ID Numbers: |
MALG-0816 |
| Study First Received: | August 14, 2009 |
| Results First Received: | January 31, 2014 |
| Last Updated: | May 14, 2014 |
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 Permethrin |
Malathion Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinesterase Inhibitors Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 21, 2017