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

Piedmont Pharmaceuticals

Status: Completed

Conditions: Pediculus Capitis

Treatments: Device: Apply Liquid Then Comb Out

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02997904

PP-16-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 2 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Resultz Lice and Egg Elimination Kit

Experimental group

Description:

Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour

Treatment:

Device: Apply Liquid Then Comb Out

Placebo Lice and Egg Elimination Kit

Placebo Comparator group

Description:

20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour

Treatment:

Device: Apply Liquid Then Comb Out