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NCT00752973 · ClinicalTrials.gov registry record · Phase 2
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
A Phase 2 study of Pediculosis, sponsored by Sun Pharmaceutical Industries.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT00752973: Completed Phase 2 study of Pediculosis, sponsored by Sun Pharmaceutical Industries.
NCT00752973 is a Phase 2 study of Pediculosis that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00752973, a Phase 2 study of Pediculosis, has completed, sponsored by Sun Pharmaceutical Industries.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Each patient (aged 6 - 24 months) was assessed at 1 hour (Day 0). The mean percent change (reduction) in plasma and RBC cholinesterase activity from baseline to 1 hr after application was calculated and accompanied by 95% confidence intervals. If the half-widths of the derived confidence intervals are sufficiently narrow, it will demonstrate that any observed reductions in plasma and RBC cholinesterase activity fall within established safety guidelines. Concentration of RBC-cholinesterase (RBC
Conditions Studied
Interventions
- DRUG MALG (malathion) Treatment
Study Locations (2)
Arkansas
- Investigator Site - Bentonville
- Investigator Site - Jonesboro
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
What the finished NCT00752973 record still lists
NCT00752973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Pediculosis appearing as the primary indexed condition, and to 1 intervention - of which MALG (malathion) Treatment is the first listed.
NCT00752973 reports a single indexed study location in Arkansas.
Frequently Asked Questions
What is clinical trial NCT00752973 about?
NCT00752973 is a clinical study titled "Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice". 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...
What is the current status of trial NCT00752973?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2008-09. Estimated completion is 2012-01.
What conditions does trial NCT00752973 study?
This clinical trial studies the following conditions: Pediculosis.
What interventions are being tested in trial NCT00752973?
The interventions under investigation include: MALG (malathion) Treatment (DRUG).
Who is sponsoring clinical trial NCT00752973?
This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00752973 being conducted?
This trial has 2 study locations across Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00752973's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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