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

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ClinicalTrials.gov Identifier: NCT02997904
Recruitment Status : Completed
First Posted : December 20, 2016
Results First Posted : August 31, 2017
Last Update Posted : August 31, 2017
Sponsor:
Collaborator:
Lice Solutions Resource Network (LSRN) Research
Information provided by (Responsible Party):
Piedmont Pharmaceuticals, LLC

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.

Condition or disease Intervention/treatment Phase
Pediculus Capitis Device: Apply Liquid Then Comb Out Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official 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
Actual Study Start Date : December 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : February 2017

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 Name: 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 Name: Resultz Application




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997904


Locations
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United States, Florida
Lice Solution Resource Network Research
West Palm Beach, Florida, United States, 33407
Sponsors and Collaborators
Piedmont Pharmaceuticals, LLC
Lice Solutions Resource Network (LSRN) Research
Investigators
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Principal Investigator: Katie Shepherd Lice Solutions Resource Network Research

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Responsible Party: Piedmont Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02997904     History of Changes
Other Study ID Numbers: PP-16-001
First Posted: December 20, 2016    Key Record Dates
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Piedmont Pharmaceuticals, LLC:
lice comb
human head lice infestations
combing solution