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CompletedNCT03257943Updated May 18, 2018

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

A Phase 1 interventional study of Ivermectin Lotion, 0.5% and SKLICE (ivermectin) Lotion, 0.5% in Lice; Head Lice, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.

Sponsored by Taro Pharmaceuticals USA · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
413
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Lice; Head Lice

Browse trials for

03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
413 participants (actual)

Study arms

  • Experimental
    Ivermectin Lotion, 0.5%

    One 10 minute application, under at-home use conditions

    Drug: Ivermectin Lotion, 0.5%

  • Active comparator
    SKLICE (ivermectin) Lotion, 0.5%

    One 10 minute application, under at-home use conditions

    Drug: SKLICE (ivermectin) Lotion, 0.5%

  • Placebo comparator
    Vehicle of the Test product

    One 10 minute application, under at-home use conditions

    Drug: Vehicle of the Test product

Interventions

  • DrugIvermectin Lotion, 0.5%

    Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)

    Also known as: ivermectin

  • DrugSKLICE (ivermectin) Lotion, 0.5%

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

    Also known as: ivermectin

  • DrugVehicle of the Test product

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

    Also known as: placebo

05

What researchers measure

Primary outcomes

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

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

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

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Study locations

1 site
  • Taro Pharmaceuticals USA Inc.
    Hawthorne, New York 10532, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03257943
Lead sponsor
Taro Pharmaceuticals USA
Responsible party
Sponsor
First posted
Aug 22, 2017
Start date
Mar 20, 2017
Primary completion
Jun 27, 2017
Completion
Aug 18, 2017
Last update
May 18, 2018

Study contacts

Catawba Research
study chair · http://catawbaresearch.com/contact/

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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