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

Sun Pharmaceutical Industries, Inc.413 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

413

Conditions

Lice; Head Lice

Interventions

Ivermectin Lotion, 0.5%DRUG

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

SKLICE (ivermectin) Lotion, 0.5%DRUG

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

Vehicle of the Test productDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Outcomes

Primary Outcomes

Demonstration of Bioequivalence in proportion of index subjects who are lice free

Time frame: Day 15 (14 days after application of study treatment)

Data from ClinicalTrials.gov

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