Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice

Completed · Phase 2/Phase 3

Conditions studied: Pediculosis

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

NCT00752973

Run by

Sun Pharmaceutical Industries, Inc.

People needed

12

Starts

2008-09-01

Expected to finish

2012-01-01

Last updated by the study team

2014-08-07

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

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 — Bentonville, Arkansas, United States
• Investigator Site — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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