Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

Completed · Phase 3

Conditions studied: Lice Infestations

In brief

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.

Key facts

Study ID

NCT00244439

Run by

Sun Pharmaceutical Industries, Inc.

People needed

360

Starts

2005-12-01

Expected to finish

2006-12-01

Last updated by the study team

2013-12-23

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigator Site — Scottsdale, Arizona, United States
• Investigator Site — Miami, Florida, United States
• Investigator Site — St. Petersburg, Florida, United States
• Investigator Site — West Palm Beach, Florida, United States
• Investigator Site — New York, New York, United States
• Investigator Site — Miamiville, Ohio, United States

Full record on ClinicalTrials.gov

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