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NCT00857948
A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation
Phase 2 trial testing ivermectin treatment conditioner in Pediculus Humanus Capitis (Head Lice) in 78 participants. Completed in 1 April 2009.
1 April 2009
Quick facts
| Lead sponsor | Topaz Pharmaceuticals Inc |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 78 |
| Start date | 1 March 2009 |
| Primary completion | 1 April 2009 |
| Estimated completion | 1 April 2009 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ivermectin treatment conditioner — full drug profile →
- Placebo, vehicle control — full drug profile →
Conditions studied
- Pediculus Humanus Capitis (Head Lice) — all drugs for Pediculus Humanus Capitis (Head Lice) →
Sponsor
Topaz Pharmaceuticals Inc — full company profile →
Who can join
6 Months and older, any sex, with Pediculus Humanus Capitis (Head Lice). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control)
Time frame: Day 1 through Day 15 post-application
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Sponsor's own description
This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00857948
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
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Related trials
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00857948 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Topaz Pharmaceuticals Inc
- Last refreshed: 1 March 2012
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00857948.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing