Trials / Completed
CompletedNCT00752973
Safety and Tolerability of a Novel Malathion Formulation in Children Age 6-24 Months With Head Lice
Phase II, Multi-Center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Sun Pharmaceutical Industries, Inc. · Industry
- Sex
- All
- Age
- 6 Months – 24 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MALG (malathion) Treatment | MALG applied for 30 minutes |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2011-12-01
- Completion
- 2012-01-01
- First posted
- 2008-09-16
- Last updated
- 2014-08-07
- Results posted
- 2014-04-03
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00752973. Inclusion in this directory is not an endorsement.