Trial Outcomes & Findings for Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis (NCT NCT06006455)

Results Overview

Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows: (i) Clinical Cure: Measurement of clear nail increase as the following: * at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or * complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment. The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month. (ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

12 months

Results posted on

2025-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	Erchonia LunulaLaser The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11. Erchonia LunulaLaser: 405nm violet and 635nm red laser light therapy.
Overall Study STARTED	28
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of the Erchonia® LunulaLaser™ for the Treatment of Toenail Onychomycosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erchonia LunulaLaser n=28 Participants The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11. Erchonia LunulaLaser: 405nm violet and 635nm red laser light therapy.
Age, Continuous	74.32 years STANDARD_DEVIATION 92.96 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	27 Participants n=5 Participants
Race/Ethnicity, Customized Asian/ Pacific Islander	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Complete Cure criteria is defined as a subject/toenail satisfying both the 'Clinical Cure' and the 'Mycological Cure' criteria in order to be considered a study responder, defined as follows: (i) Clinical Cure: Measurement of clear nail increase as the following: * at least 12 mm increase in clear nail of the great toenail, with evidence of distal growth of the affected area, 12 months after the first treatment; or * complete clearance 12 months after the first treatment if less than 12 mm distal nail was involved prior to treatment. The response should be progressive in at least 2 sequential timepoints that are at least 3 months apart, with projected increase of at least 1 mm per month. (ii) Mycologic Cure: both negative KOH and negative Fungal Culture results (or two serial negative Fungal Culture results)

Outcome measures

Outcome measures
Measure	Erchonia LunulaLaser n=25 Participants The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11. Erchonia LunulaLaser: 405nm violet and 635nm red laser light therapy.
Percentage of Participants With Toenails Attaining Complete Cure	6 Participants

SECONDARY outcome

Timeframe: 14 months

Mycological cure is defined as negative culture for dermatophytes using the BioMed InTray™ DM Culture

Outcome measures

Outcome measures
Measure	Erchonia LunulaLaser n=25 Participants The Erchonia LunulaLaser emits red light (635 nm) and violet light (405 nm) to the affected toenail for 12 minutes per treatment. The treatment phase involves an initial weekly treatment administration phase, 1 treatment a week for 4 weeks, followed by an every two-month maintenance treatment administration phase, months 3, 5, 7, 9, and 11. Erchonia LunulaLaser: 405nm violet and 635nm red laser light therapy.
Mycologic Cure	14 Participants

Adverse Events

Erchonia LunulaLaser

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Affairs Manager

Erchonia Corporation

Phone: 8882420571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place