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 Malathion Gel 0.5% Formulation, for the Control of Head Lice in Pediatric Subjects and Adult Subjects With Pediculosis Capitis
1 other identifier
interventional
403
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2009
Shorter than P25 for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 14, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
June 13, 2014
CompletedJune 13, 2014
May 1, 2014
7 months
August 14, 2009
January 31, 2014
May 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (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) 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))
3 weeks
Secondary Outcomes (1)
Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF).
3 weeks
Study Arms (2)
Malathion Gel
EXPERIMENTALMalathion gel 0.5% 30 minute application
Nix Crème Rinse
ACTIVE COMPARATORNix Crème Rinse applied to scalp for 10 minutes
Interventions
Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present.
Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present.
Eligibility Criteria
You may qualify if:
- Confirmed active head lice infestation
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Investigator Site
Hot Springs, Arkansas, United States
Investigator Site
Sacramento, California, United States
Investigator Site
Kissimmee, Florida, United States
Investigator Site
Miami, Florida, United States
Investigator Site
Ormond Beach, Florida, United States
Investigator Site
Picayune, Mississippi, United States
Investigator Site
San Antonio, Texas, United States
Related Publications (1)
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.
PMID: 17845167RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Research
- Organization
- Taro Pharmaceuticals U.S.A., Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2009
First Posted
August 21, 2009
Study Start
August 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
June 13, 2014
Results First Posted
June 13, 2014
Record last verified: 2014-05