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NCT00994422 · ClinicalTrials.gov registry record · Phase 2
Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects
A Phase 2 study of Head Lice, sponsored by Topaz Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 264
- Enrollment target
- 12
- Study locations
NCT00994422: Completed Phase 2 study of Head Lice, sponsored by Topaz Pharmaceuticals.
NCT00994422 is a Phase 2 study of Head Lice that has completed, run by Topaz Pharmaceuticals. The registered enrollment target is 264 participants, above the 64-participant average among 5 other Head Lice trials with a reported enrollment target (313% higher). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00994422, a Phase 2 study of Head Lice, has completed, sponsored by Topaz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 264 participants
- Enrollment target
- 12
- Study locations
Study Summary
The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.
Primary Outcome
Treatment success was defined as the absence of live lice and was determined by visual examination of hair and scalp by a trained evaluator.
Conditions Studied
Interventions
- DRUG Ivermectin cream
- DRUG vehicle control
Study Locations (12)
Florida
- Lice Cleanique, LLC - Delray Beach
- Hill-Top Research Corp - St. Petersburg
- LSRN - West Palm Beach
Arizona
- Cactus Kids Pediatrics - Yuma
California
- Impact Clinical Trials - Los Angeles
Minnesota
- Minnesota Clinical Study Center - Fridley
New Mexico
- Lovelace Scientific Resources, Inc. - Albuquerque
North Carolina
- Haywood Pediatric Adolescent Medicine Group, PA - Clyde
Ohio
- Hill Top Research Corp. - Miamiville
Tennessee
- LSRN - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 264 participants |
| Start Date | 2009-10 |
| Est. Completion | 2009-12 |
| Phase | Phase 2 |
What the finished NCT00994422 record still lists
NCT00994422 is an interventional study that assigns participants to a tested intervention. The registered 264 participants enrollment target is mid-sized for trials with a published cap, above the 64-participant average among 5 other Head Lice trials with a reported enrollment target (313% higher).
The record links to 1 condition, with Head Lice appearing as the primary indexed condition, and to 2 interventions - of which Ivermectin cream is the first listed.
NCT00994422 lists 12 locations in 10 states (Florida, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT00994422 about?
NCT00994422 is a clinical study titled "Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects". The purpose of this study is to compare the safety and efficacy of a 0.5% ivermectin cream to a placebo in subjects infested with head lice when used in an "at home" environment.
What is the current status of trial NCT00994422?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 264 participants. The study started on 2009-10. Estimated completion is 2009-12.
What conditions does trial NCT00994422 study?
This clinical trial studies the following conditions: Head Lice.
What interventions are being tested in trial NCT00994422?
The interventions under investigation include: Ivermectin cream (DRUG), vehicle control (DRUG).
Who is sponsoring clinical trial NCT00994422?
This trial is sponsored by Topaz Pharmaceuticals, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00994422 being conducted?
This trial has 12 study locations across Arizona, California, Florida, Minnesota, New Mexico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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