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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

413 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-20

Study Completion Date

2017-08-18

Brief Summary

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

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Detailed Description

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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

Conditions

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Lice; Head Lice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ivermectin Lotion, 0.5%

One 10 minute application, under at-home use conditions

Group Type EXPERIMENTAL

Ivermectin Lotion, 0.5%

Intervention Type DRUG

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

SKLICE (ivermectin) Lotion, 0.5%

One 10 minute application, under at-home use conditions

Group Type ACTIVE_COMPARATOR

SKLICE (ivermectin) Lotion, 0.5%

Intervention Type DRUG

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

Vehicle of the Test product

One 10 minute application, under at-home use conditions

Group Type PLACEBO_COMPARATOR

Vehicle of the Test product

Intervention Type DRUG

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

Interventions

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Ivermectin Lotion, 0.5%

Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

Intervention Type DRUG

SKLICE (ivermectin) Lotion, 0.5%

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

Intervention Type DRUG

Vehicle of the Test product

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

Intervention Type DRUG

Other Intervention Names

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ivermectin ivermectin placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes