Phase 3
N=254
Efficacy, Safety and Tolerability of a Novel Malathion Formulation in Patients 2 Years and Older With Head Lice
Pediculosis
Bottom Line
View on ClinicalTrials.gov: NCT00927472 ↗Enrolled (actual)
254
Serious AEs
0.4%
Results posted
Aug 2014
Primary outcome: Primary: Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment. — 82.98; 62.50 percentage of subjects — p=0.0386
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Malathion gel 0.5% (Drug); Permethrin 1% rinse (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Index Subjects Free of Any of Lice 14 Days After Their Last Treatment. |
82.98; 62.50 | 0.0386 sig |
| PRIMARY Proportion of Index Subjects Lice-free 2 Weeks After Their Last Treatment |
78.72; 58.33 | 0.0490 sig |
| PRIMARY Proportion of Index Subjects Lice-free 14 Days After Their Last Treatment |
91.30; 71.70 | 0.0002 sig |
| PRIMARY Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit.(LOCF) |
91.74; 72.97 | 0.0003 sig |
| PRIMARY Proportion of All Randomized Subjects Who Were Treated and Returned for at Least One Post-treatment Visit (Non-LOCF). |
86.78; 68.47 | 0.0012 sig |
| SECONDARY Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (LOCF)) |
80.95; 70.00 | 0.3675 |
| SECONDARY Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Efficacy ITT (Non LOCF)) |
76.19; 65.00 | 0.3817 |
| SECONDARY Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the PPP |
90.38; 80.95 | 0.1059 |
| SECONDARY Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (LOCF) |
90.91; 82.02 | 0.1088 |
| SECONDARY Proportion of Subjects Who Were Considered Treatment Success 14 Days After Their First Treatment in the Modified ITT (Non LOCF) |
85.45; 76.40 | 0.1527 |
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.
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 (NCT00927472). 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.