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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

5% Lice Asphyxiator lotion - Summers Laboratories, Inc.

About this trial

This is an interventional treatment trial for Head Lice

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Males and females 6 months of age or older. 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. Agree not to use any other pediculicides or medicated hair grooming products during the duration of the study. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form. 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. Subject is willing to participate in the study, and abide by the protocol requirements. - Exclusion Criteria: Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days. Known hypersensitivity to any ingredient in the product formulation.

Sites / Locations

Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
Alegent Health, Harmony Street, 2nd Floor
Dermatology Research Associates 7691 Five Mile Road, Suite 312
Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00301340

First Posted

March 8, 2006

Last Updated

May 25, 2007

Sponsor

Summers Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00301340

Brief Title

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

Official Title

An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice

Study Type

Interventional

2. Study Status

Record Verification Date

May 2007

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Summers Laboratories

4. Oversight

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Lice

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Enrollment

200 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

5% Lice Asphyxiator lotion - Summers Laboratories, Inc.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: Males and females 6 months of age or older. 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. Agree not to use any other pediculicides or medicated hair grooming products during the duration of the study. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form. 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. Subject is willing to participate in the study, and abide by the protocol requirements. - Exclusion Criteria: Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days. Known hypersensitivity to any ingredient in the product formulation.

Overall Study Officials: