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NCT04320173 · ClinicalTrials.gov registry record · Phase 1

Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects

A Phase 1 study, sponsored by Scilex Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
47
Enrollment target

NCT04320173: Completed Phase 1 study, sponsored by Scilex Pharmaceuticals.

NCT04320173 is a Phase 1 study that has completed, run by Scilex Pharmaceuticals. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04320173, a Phase 1 study, has completed, sponsored by Scilex Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
47 participants
Enrollment target

Study Summary

The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).

Primary Outcome

Adhesion of the product to the skin is assessed by the FDA 0-4 scoring system. The scoring for adhesion is indicated as follows: 0 = ≥ 90% Adhered (essentially no lift off the skin), 1 = ≥ 75% to \< 90% Adhered (some edges only lifting off the skin), 2 = ≥ 50% to \< 75% Adhered (less than half of the patch lifting off the skin), \> 0% to \< 50% Adhered but not detached (more than half of the patch lifting off the skin without falling off), and 4 = 0% adhered (patched completely detached). Adhesi

Interventions

  • DRUG Lidocaine patch 1.8%
  • DRUG Lidocaine patch 5%
  • DRUG Lidocaine medicated plaster 5%

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2017-02-14
Est. Completion 2017-03-22
Phase Phase 1
Scilex Pharmaceuticals

7 total trials

What the finished NCT04320173 record still lists

NCT04320173 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).

The record links to 0 conditions, and to 3 interventions - of which Lidocaine patch 1.8% is the first listed.

NCT04320173 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04320173 about?

NCT04320173 is a clinical study titled "Adhesion Performance Study of Lidocaine Topical System 1.8% Compared to Lidocaine Patch 5% and Lidocaine Medicated Plaster 5% in Healthy, Adult, Human Subjects". The primary objective of this study was to evaluate the adhesion performance of ZTlido® (lidocaine topical system) 1.8% compared to adhesion performance for Lidoderm® (lidocaine patch 5%) and Versatis® (lidocaine medicated plaster 5%).

What is the current status of trial NCT04320173?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2017-02-14. Estimated completion is 2017-03-22.

What interventions are being tested in trial NCT04320173?

The interventions under investigation include: Lidocaine patch 1.8% (DRUG), Lidocaine patch 5% (DRUG), Lidocaine medicated plaster 5% (DRUG).

Who is sponsoring clinical trial NCT04320173?

This trial is sponsored by Scilex Pharmaceuticals, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04320173's enrollment target sits among peer trials

47 1053rd of 2000 higher than 943 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 NCT04320173, the US trial registry maintained by the National Library of Medicine. NCT04320173 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.