Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

Stopped early · Phase 2

Conditions studied: Lice Infestations

In brief

In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Key facts

Study ID

NCT00291057

Run by

Sun Pharmaceutical Industries, Inc.

People needed

30

Starts

2006-02-01

Expected to finish

2006-12-01

Last updated by the study team

2013-12-23

Who can join

Age: 1 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed active head lice infestation
• Parent or guardian must be able to apply treatment

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

Where it is running

• Investigator Site — Scottsdale, Arizona, 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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