NCT03337490View on ClinicalTrials.gov

A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice

PHASE3CompletedINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

October 2, 2017

Primary Completion Date

December 4, 2017

Study Completion Date

December 18, 2017

Conditions
Head Lice
Interventions
DRUG

Ivermectin 0.5% Topical Application Lotion

Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.

DRUG

Ivermectin 0.5% Topical Application Lotion [SKLICE]

Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.

DRUG

Placebo 0% Lotion

Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.

Trial Locations (6)

33186

Site 104, Miami

33313

Site 101, Plantation

33407

Site 102, West Palm Beach

37217

Site 106, Nashville

93618

Site 105, Dinuba

99352

Site 103, Richland

All Listed Sponsors
collaborator

bioRASI, LLC

INDUSTRY

lead

Mayne Pharma International Pty Ltd

INDUSTRY

NCT03337490 - A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice | Biotech Hunter | Biotech Hunter