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NCT03257943 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Lice; Head Lice, sponsored by Sun Pharmaceutical Industries.

Completed
Registry status
Phase 1
Development phase
413
Enrollment target
1
Study location

NCT03257943: Completed Phase 1 study of Lice; Head Lice, sponsored by Sun Pharmaceutical Industries.

NCT03257943 is a Phase 1 study of Lice; Head Lice that has completed, run by Sun Pharmaceutical Industries. The registered enrollment target is 413 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (588% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03257943, a Phase 1 study of Lice; Head Lice, has completed, sponsored by Sun Pharmaceutical Industries.

COMPLETED
Registry status
Phase 1
Development phase
413 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

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

Conditions Studied

Interventions

  • DRUG Ivermectin Lotion, 0.5%
  • DRUG SKLICE (ivermectin) Lotion, 0.5%
  • DRUG Vehicle of the Test product

Study Locations (1)

New York

  • Taro Pharmaceuticals USA Inc. - Hawthorne

Trial Details

FieldValue
Enrollment Target 413 participants
Start Date 2017-03-20
Est. Completion 2017-08-18
Phase Phase 1
Sun Pharmaceutical Industries

48 total trials

What the finished NCT03257943 record still lists

NCT03257943 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (588% higher).

The record links to 1 condition, with Lice; Head Lice appearing as the primary indexed condition, and to 3 interventions - of which Ivermectin Lotion, 0.5% is the first listed.

NCT03257943 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT03257943 about?

NCT03257943 is a clinical study titled "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%

What is the current status of trial NCT03257943?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 413 participants. The study started on 2017-03-20. Estimated completion is 2017-08-18.

What conditions does trial NCT03257943 study?

This clinical trial studies the following conditions: Lice; Head Lice.

What interventions are being tested in trial NCT03257943?

The interventions under investigation include: Ivermectin Lotion, 0.5% (DRUG), SKLICE (ivermectin) Lotion, 0.5% (DRUG), Vehicle of the Test product (DRUG).

Who is sponsoring clinical trial NCT03257943?

This trial is sponsored by Sun Pharmaceutical Industries, which has 48 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03257943 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT03257943's enrollment target sits among peer trials

413 72nd of 2000 higher than 1,928 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03257943, the US trial registry maintained by the National Library of Medicine. NCT03257943 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.