Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice

Completed · Phase 3 · Has a placebo group

Conditions studied: Pediculosis

In brief

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.

Key facts

Study ID

NCT00963508

Run by

Sun Pharmaceutical Industries, Inc.

People needed

403

Starts

2009-08-01

Expected to finish

2010-03-01

Last updated by the study team

2014-06-13

Who can join

Age: 2 and older. 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 — 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

Full record on ClinicalTrials.gov

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