A Bioequivalence Study, Comparing Two Formulations of Ivermectin Lotion, 0.5%

A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Ivermectin Lotion, 0.5% in the Treatment of Subjects With Active Infestation With Head Lice and Their Ova

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03257943

Enrollment

413

Registered

2017-08-22

Start date

2017-03-20

Completion date

2017-08-18

Last updated

2018-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lice; Head Lice

Brief summary

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%

Detailed description

A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova

Interventions

DRUGIvermectin Lotion, 0.5%

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

DRUGSKLICE (ivermectin) Lotion, 0.5%

SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)

DRUGVehicle of the Test product

Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects 18 years of age or older must have provided IRB-approved written informed consent and sign a HIPAA authorization. * Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion criteria

* Subjects with a history of hypersensitivity or allergy to or any component of the study product. * Subject with history of irritation or sensitivity to pediculicides or hair care products.

Design outcomes

Primary

Measure	Time frame	Description
Demonstration of Bioequivalence in proportion of index subjects who are lice free	Day 15 (14 days after application of study treatment)	Demonstration of Bioequivalence in proportion of index subjects who are lice free

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026