CompletedPhase 3

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

United States403 participantsStarted 2009-08

Plain-language summary

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.

Who can participate

Age range2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed active head lice infestation Exclusion Criteria: * 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

What they're measuring

Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF)

Timeframe: 3 weeks

Trial details

NCT IDNCT00963508

SponsorSun Pharmaceutical Industries, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-03

Results submitted2014-01-31

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