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

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Lice; Head Lice

Treatments: Drug: Vehicle of the Test product; Drug: SKLICE (ivermectin) Lotion, 0.5%; Drug: Ivermectin Lotion, 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03257943

IVRL 1604

Details and patient eligibility

About

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

Full 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

Enrollment: 413 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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413 participants in 3 patient groups, including a placebo group

Ivermectin Lotion, 0.5%

Experimental group

Description:

One 10 minute application, under at-home use conditions

Treatment:

Drug: Ivermectin Lotion, 0.5%

SKLICE (ivermectin) Lotion, 0.5%

Active Comparator group

Description:

One 10 minute application, under at-home use conditions

Treatment:

Drug: SKLICE (ivermectin) Lotion, 0.5%

Vehicle of the Test product

Placebo Comparator group

Description:

One 10 minute application, under at-home use conditions

Treatment:

Drug: Vehicle of the Test product