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

NCT02997904 | Completed Results FDA Device

• 1 other identifier: PP-16-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediculus Capitis

Keywords

lice comb; human head lice infestations; combing solution

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total Number of Lice Removed, Total Number of Eggs Removed

  1 hour

Study Arms (2)

Resultz Lice and Egg Elimination Kit

EXPERIMENTAL

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

Placebo Lice and Egg Elimination Kit

PLACEBO COMPARATOR

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

Interventions

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

Also known as: Resultz Application

Placebo Lice and Egg Elimination Kit; Resultz Lice and Egg Elimination Kit

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piedmont Pharmaceuticals, LLC: lead
• Lice Solutions Resource Network (LSRN) Research: collaborator

Study Sites (1)

Lice Solution Resource Network Research

West Palm Beach, Florida, 33407, United States

Location

Results Point of Contact

• Title: Dr. Kathy Palma
• Organization: Piedmont Pharmaceuticals

kpalma@piedmontpharma.com

336 544 0320

Study Officials

• Katie Shepherd

  Lice Solutions Resource Network Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: December 20, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)