Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
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ClinicalTrials.gov Identifier: NCT00963508 |
Recruitment Status :
Completed
First Posted : August 21, 2009
Results First Posted : June 13, 2014
Last Update Posted : June 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pediculosis | Drug: Malathion gel 0.5% Drug: Permethrin 1% rinse (Nix Crème) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 403 participants |
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 |
Study Start Date : | August 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | March 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Malathion Gel
Malathion gel 0.5% 30 minute application
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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. |
- 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))
- 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)

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Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963508
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 |
Responsible Party: | Taro Pharmaceuticals USA |
ClinicalTrials.gov Identifier: | NCT00963508 |
Other Study ID Numbers: |
MALG-0816 |
First Posted: | August 21, 2009 Key Record Dates |
Results First Posted: | June 13, 2014 |
Last Update Posted: | June 13, 2014 |
Last Verified: | May 2014 |
Head Lice |
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 |