Head Lice
Conditions
Brief summary
This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.
Interventions
DRUGSummers 5% L.A.
Sponsors
Summers Laboratories
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females 6 months of age or older. 2. Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline. 3. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study. 4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. 5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form. 6. Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language. 7. Subject is willing to participate in the study, and abide by the protocol requirements. \-
Exclusion criteria
1. Participation in any clinical study within the past 30 days. 2. Known hypersensitivity to any ingredient in the product formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment success is defined as the absence of live lice. | — |
Secondary
| Measure | Time frame |
|---|---|
| The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit. | — |
Countries
United States
Outcome results
None listed