Lice Infestations
Conditions
Keywords
Head Lice, Pediculosis capitis
Brief summary
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion. In a previous phase II study, a novel, easy-to-use malathion 0.5% formulation was found to be a safe treatment for head lice. The current study will compare the efficacy and safety of this novel formulation of malathion with OVIDE and with an over-the-counter permethrin product.
Interventions
DRUGMALG
30 minute application
DRUGOvide (malathion) lotion 0.05%
8-12 hour application
DRUGPermethrin 1%
10 minute application
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed active head lice infestation * Patient, parent or guardian must be able to apply the treatment * Entire household must be screened * All infested persons must agree to participate
Exclusion criteria
* Allergy to pediculicides, hair care products or chrysanthemums * Scalp conditions other than head lice * Previous head lice treatment within the past 4 weeks * Female patients who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure of Head Lice | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety of treatments | 4 weeks |
Countries
United States
Outcome results
None listed