TerminatedPhase 2

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

Stopped: Lack of enrollment

United States30 participantsStarted 2006-02

Plain-language summary

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.

Who can participate

Age range6 Months – 24 Months

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 * Parent or guardian must be able to apply treatment 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

Change in cholinesterase level

Timeframe: 1 day

Trial details

NCT IDNCT00291057

SponsorSun Pharmaceutical Industries, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2006-10

View on ClinicalTrials.gov More Lice Infestations trials