Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Information source: Taro Pharmaceuticals USA
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lice Infestations
Intervention: MALG (Drug); Ovide (malathion) lotion 0.05% (Drug); Permethrin 1% (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Taro Pharmaceuticals USA Official(s) and/or principal investigator(s):
John Goodman, MD, Principal Investigator, Affiliation: Hill Top Research
Robert E Lewine, MD, Principal Investigator, Affiliation: Hill Top Research
Wanda M Boote, MD, Principal Investigator, Affiliation: Hill Top Research
Jan Fu, MD, PhD, Principal Investigator, Affiliation: Hill Top Research
Terri Meinking, Principal Investigator, Affiliation: Global Health Associates Miami
Micheal J Alaimo, RPh, DO, Principal Investigator, Affiliation: Hill Top Research
Summary
Current treatments for head lice include over-the-counter products such as permethrin and
prescription products such as OVIDE (malathion 0. 5%) lotion. In a previous phase II study, a
novel, easy-to-use malathion 0. 5% formulation was found to be a safe treatment for head lice.
The current study will compare the efficacy and safety of this novel formulation of
malathion with OVIDE and with an over-the-counter permethrin product.
Clinical Details
Official title: A Multi-Center Phase III Study to Evaluate MALG, a Novel Malathion 0.05%Formulation, for the Control of Head Lice in Pediatric and Adult Subjects With Pediculosis Capitis
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Cure of Head Lice
Secondary outcome: Safety of treatments
Eligibility
Minimum age: 2 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Confirmed active head lice infestation
- Patient, parent or guardian must be able to apply the treatment
- Entire household must be screened
- All infested persons must agree to participate
Exclusion Criteria:
- Allergy to pediculicides, hair care products or chrysanthemums
- Scalp conditions other than head lice
- Previous head lice treatment within the past 4 weeks
- Female patients who are pregnant or nursing
Locations and Contacts
Scottsdale, Arizona, United States
West Palm Beach, Florida, United States
St. Petersburg, Florida, United States
Miami, Florida, United States
New York, New York, United States
Miamiville, Ohio, United States
Additional Information
Starting date: December 2005
Ending date: December 2006
Last updated: April 2, 2008
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