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Pharmacokinetics of Malathion Gel 0.5% and Malathion 0.5% Lotion (Ovide) in Patients With Head Lice

NCT00927407 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-12-24

No results posted yet for this study

Summary

In this study, 24 adult patients with head lice will be treated with a topical malathion head lice treatment; 12 patients will be treated with a novel product, Malathion Gel, 0.5%, and other 12 patients will be treated with Ovide Lotion 0.5% marketed by Taro Pharmaceuticals USA, Inc. The primary objective of this study is to compare the blood level exposure of Malathion 0.5% Gel to that of the OVIDE Lotion 0.5%.

Conditions

  • Pediculosis

Interventions

DRUG

Malathion gel 0.5%

Malathion gel 0.5% applied to the scalp for 30 minutes

DRUG

Malathion lotion 0.5%

Malathion lotion 0.5% applied to scalp for 12 hours

Sponsors & Collaborators

  • Sun Pharmaceutical Industries, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00927407 on ClinicalTrials.gov