Skip to main content
OpenTrials
Completed

NCT Number: NCT00301340

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head Lice

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5% Lice Asphyxiator lotion - Summers Laboratories, Inc.

Drug

Sponsors and collaborators

Lead sponsor

Summers Laboratories

Industry

Registry information

Official study title

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

Important dates

Study start
2006
First posted
Mar 10, 2006
Registry last updated
May 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.