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

Summers 5% L.A.

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. 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 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

Treatment success is defined as the absence of live lice.

Secondary Outcome Measures

The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Full Information

NCT ID

NCT00301327

First Posted

March 8, 2006

Last Updated

May 25, 2007

Sponsor

Summers Laboratories

1. Study Identification

Unique Protocol Identification Number

NCT00301327

Brief Title

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

Official Title

A Multi-Center, Randomized, Vehicle Controlled, Double Blind Clinical 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

January 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

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.

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

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

120 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Summers 5% L.A.

Primary Outcome Measure Information:

Title

Treatment success is defined as the absence of live lice.

Secondary Outcome Measure Information:

Title

The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

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. 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 within the past 30 days. Known hypersensitivity to any ingredient in the product formulation.

Overall Study Officials: