NCT05626270 is a NA clinical trial of LunulaLaser OTC in Onychomycosis, sponsored by Erchonia Corporation.

Who is sponsoring NCT05626270?

NCT05626270 is sponsored by Erchonia Corporation.

What drugs are being tested in NCT05626270?

Interventions in NCT05626270: LunulaLaser OTC.

What condition does NCT05626270 study?

NCT05626270 studies Onychomycosis.

Is NCT05626270 still recruiting?

NCT05626270 is currently completed. Last updated 23 May 2024.

Are results published for NCT05626270?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-05-23 · How we verify

NCT05626270

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Human Factors Testing for OTC Use of the Erchonia® LunulaLaser

Completed NA Results posted Last updated 23 May 2024

What this trial tests

NA trial testing LunulaLaser OTC in Onychomycosis in 15 participants. Completed in 23 December 2022.

Timeline

4 June 2021

Primary endpoint
23 December 2022

23 December 2022

Quick facts

Lead sponsor	Erchonia Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	15
Start date	4 June 2021
Primary completion	23 December 2022
Estimated completion	23 December 2022
Sites	1 location across United States

Drugs / interventions tested

LunulaLaser OTC

Conditions studied

Onychomycosis — all drugs for Onychomycosis →

Sponsor

Erchonia Corporation — full company profile →

Who can join

18 and older, any sex, with Onychomycosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Human Factors Primary · Each study session was completed on a single day, for up to 120 minutes

The outcome measure identifies the number of subject users that were defined as a study "pass". A subject user is determined a study 'pass if the subject satisfactorily completes both the device setup and treatment procedure. If the subject user does not satisfactorily complete either one or both of device setup and/or treatment procedure the subject will be determined a study "fail".

Group	Value	95% CI
LunulaLaser OTC	15

Sponsor's own description

Human factors validation testing to assess the intended user's ability to correctly, safely, and effectively set-up, activate and operate the LunulaLaser™ OTC, to administer a treatment to a suitably qualified client, and to understand the information contained in the Erchonia LunulaLaser™ OTC Installation and Proper Use Reference Guide and box labeling.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Onychomycosis

Currently open trials in the same condition.

NCT06327295 — A Study of ATB1651 in Adults With Mild to Moderate Onchomycosis · Phase 2 · recruiting
NCT05482763 — Mycosis Culture Collection From Dermatological Isolated · active not recruiting

Other Erchonia Corporation trials

Trials by the same sponsor.

NCT06941610 — An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity · NA · recruiting
NCT06912646 — Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain · NA · recruiting
NCT06656325 — An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis · NA · recruiting
NCT05954065 — An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat · completed
NCT05674292 — An Evaluation of the Effect of the Erchonia Corporation Violet Zerona® Z6 for Body Contouring · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05626270 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Erchonia Corporation
Last refreshed: 23 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05626270.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing