Phase 3
Completed N=403
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
Pediculosis
Source: ClinicalTrials.gov NCT00963508 ↗
Enrolled (actual)
403
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcomePrimary: Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) — 86.67; 45.33 percentage of subjects — p=<0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Index Subjects Free of Any Lice 14 Days After Their Last Treatment in the Modified ITT (LOCF) |
86.67; 45.33 | <0.0001 sig |
| SECONDARY Proportion of Subjects Who Were Considered a Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF). |
89.90; 55.43 | 0.0005 sig |
Eligibility Criteria
Inclusion Criteria
- Confirmed active head lice infestation
Exclusion Criteria
- Allergy to pediculicides or hair care products
- Scalp conditions other than head lice
- Previous head lice treatment within the past 4 weeks
- Current antibiotic treatment
Data sourced from ClinicalTrials.gov (NCT00963508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.