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COMPLETED Phase 3

Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice

NCT00244439 · View on ClinicalTrials.gov ↗

Study Summary

Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.

Conditions Studied

Interventions

  • DRUG MALG
  • DRUG Ovide (malathion) lotion 0.05%
  • DRUG Permethrin 1%

Study Locations (6)

Florida

  • Investigator Site — Miami
  • Investigator Site — St. Petersburg
  • Investigator Site — West Palm Beach

Arizona

  • Investigator Site — Scottsdale

New York

  • Investigator Site — New York

Ohio

  • Investigator Site — Miamiville

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2005-12
Est. Completion 2006-12
Phase Phase 3

Sponsor

Sun Pharmaceutical Industries

20 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00244439

The ClinicalTrials.gov registry entry for NCT00244439 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sun Pharmaceutical Industries, which has 20 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lice Infestations appearing as the primary indexed condition, and to 3 interventions — of which MALG is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00244439 reports 6 study locations spanning 4 distinct geographic areas — top geographies include Florida, Arizona, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00244439 about?

NCT00244439 is a clinical study titled "Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice". Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will ...

What is the current status of trial NCT00244439?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 360 participants. The study started on 2005-12. Estimated completion is 2006-12.

What conditions does trial NCT00244439 study?

This clinical trial studies the following conditions: Lice Infestations. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00244439?

The interventions under investigation include: MALG (DRUG), Ovide (malathion) lotion 0.05% (DRUG), Permethrin 1% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00244439?

This trial is sponsored by Sun Pharmaceutical Industries, which has 20 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00244439 being conducted?

This trial has 6 study locations across Arizona, Florida, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial