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NCT00963508 · ClinicalTrials.gov registry record · Phase 3
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
A Phase 3 study, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
NCT00963508: Completed Phase 3 study, sponsored by Sun Pharmaceutical Industries.
NCT00963508 is a Phase 3 study that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 403 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00963508, a Phase 3 study, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
Study 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.
Primary Outcome
The primary efficacy variable was the proportion of index subjects who were considered a Treatment Success 14 days after their last treatment (Day 14 visit if only treated on Day 1, Day 21 visit if treated on Day 1 and Day 7) Treatment Success in the Efficacy ITT (LOCF) index subjects: 150 from 403 randomized (the youngest subject in the household that met the index case criteria (having nits and at least 3 live lice))
Interventions
- DRUG Malathion gel 0.5%
- DRUG Permethrin 1% rinse (Nix Crème)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2009-08 |
| Est. Completion | 2010-03 |
| Phase | Phase 3 |
What the finished NCT00963508 record still lists
NCT00963508 is an interventional study that assigns participants to a tested intervention. The registered 403 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Malathion gel 0.5% is the first listed.
NCT00963508 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00963508 about?
NCT00963508 is a clinical study titled "Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice". 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...
What is the current status of trial NCT00963508?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2009-08. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00963508?
The interventions under investigation include: Malathion gel 0.5% (DRUG), Permethrin 1% rinse (Nix Crème) (DRUG).
Who is sponsoring clinical trial NCT00963508?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00963508's enrollment target sits among peer trials
403 917th of 2000 higher than 1,082 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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