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: 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.

Study type: Interventional

Funder types: Industry

Identifiers

NCT00301340

SU-03-2005

Details and patient eligibility

About

Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance.

The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).

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, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.

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, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.