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Completed

NCT Number: NCT03257943

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%

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Key information

Conditions

Lice; Head Lice Ectoparasitic Infestations Infections Lice Infestations Parasitic Diseases Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, 10532, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ivermectin Lotion, 0.5%

Drug

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Other names: ivermectin

SKLICE (ivermectin) Lotion, 0.5%

Drug

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

Other names: ivermectin

Vehicle of the Test product

Drug

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

Other names: placebo

Primary outcomes

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

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

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

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2017
Registry last updated
May 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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