N/A N=100 Randomized Quadruple-blind Other

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

Pediculus Capitis

Bottom Line

View on ClinicalTrials.gov: NCT02997904 ↗

Enrolled (actual)

100

Serious AEs

0.0%

Results posted

Aug 2017

Primary outcome: Primary: The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing — 71.3; 26.1 number of lice and eggs removed — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Apply Liquid Then Comb Out (Device)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Piedmont Pharmaceuticals, LLC
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing	71.3; 26.1	<0.0001 sig
SECONDARY Total Number of Lice Removed, Total Number of Eggs Removed	40.3; 12; 31; 14.1	<0.0001 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02997904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.