Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.

Summers Laboratories

Status and phase: Completed; Phase 3

Conditions: Head Lice

Treatments: Drug: Summers 5% L.A.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00301327

SU-01-2005

Details and patient eligibility

About

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.

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind