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

Study Overview
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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.

Official Title
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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

Conditions
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Pediculus Capitis

Intervention / Treatment
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* Device: Apply Liquid Then Comb Out


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resultz Lice and Egg Elimination Kit<br>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<br>* Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour<br>* Other names: Resultz Application;|
| Placebo Comparator: Placebo Lice and Egg Elimination Kit<br>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<br>* Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour<br>* Other names: Resultz Application;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lice comb, human head lice infestations, combing solution