Skip to main content
OpenTrials
Completed

NCT Number: NCT02997904

A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects

A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pediculus Capitis

Age range

2 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lice Solution Resource Network Research

West Palm Beach, Florida, 33407, United States

About this study

Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Must have active head lice infestations (at least 1 live louse and eggs)
  • Good general health based on medical history
  • Each subject has to be consented

Exclusion criteria

  • Subjects with any condition that would compromise the study
  • History of irritation or sensitivity to pediculicides or hair care products
  • Subjects with cranial or facial implants
  • Subjects who have received radiation within the last 6 months
  • Subjects with history of heart disease
  • Subjects with history of epilepsy or seizure disorders
  • Subjects with neuro-stimulator or pacemaker
  • Subject with hair that staff cannot comb
  • Subject previously treated in study in last 30 days
  • Use of lice treatment in past 2 weeks
  • Subject unable to sense pain
  • Subject unable to communicate pain

Treatment and study plan

Apply Liquid Then Comb Out

Device

Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour

Other names: Resultz Application

Primary outcomes

  1. The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing

    Time frame: 1 hour

    A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.

Secondary outcomes

  1. Total Number of Lice Removed, Total Number of Eggs Removed

    Time frame: 1 hour

    Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately

Sponsors and collaborators

Lead sponsor

Piedmont Pharmaceuticals, LLC

Industry

Collaborators

  • Lice Solutions Resource Network (LSRN) Research

Registry information

Official study title

A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 20, 2016
Registry last updated
Aug 31, 2017

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.