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

NCT ID: NCT02997904

Last Updated: 2017-08-31

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pediculus Capitis

Keywords

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lice comb human head lice infestations combing solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Apply Liquid Then Comb Out

Intervention Type DEVICE

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

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

Group Type PLACEBO_COMPARATOR

Apply Liquid Then Comb Out

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Resultz Application

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lice Solutions Resource Network (LSRN) Research

UNKNOWN

Sponsor Role collaborator

Piedmont Pharmaceuticals, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katie Shepherd

Role: PRINCIPAL_INVESTIGATOR

Lice Solutions Resource Network Research

Locations

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Lice Solution Resource Network Research

West Palm Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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PP-16-001

Identifier Type: -

Identifier Source: org_study_id