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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediculus Capitis
• Intervention / Treatment: Device: Apply Liquid Then Comb Out

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33407
      • Lice Solution Resource Network Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Resultz Lice and Egg Elimination Kit; Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour	Device: Apply Liquid Then Comb Out; Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour; Other Names: Resultz Application
Placebo Comparator: Placebo Lice and Egg Elimination Kit; 20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour	Device: Apply Liquid Then Comb Out; Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour; Other Names: Resultz Application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing	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.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Lice Removed, Total Number of Eggs Removed	Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately	1 hour

Collaborators and Investigators

• Sponsor: Piedmont Pharmaceuticals, LLC
• Collaborators: Lice Solutions Resource Network (LSRN) Research
• Investigators: Principal Investigator: Katie Shepherd, Lice Solutions Resource Network Research

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 20, 2016

Study Record Updates

• Last Update Posted (Actual): August 31, 2017
• Last Update Submitted That Met QC Criteria: July 31, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: lice comb; human head lice infestations; combing solution
• Other Study ID Numbers: PP-16-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes