Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser

Not Applicable

Completed

• Conditions: Onychomycosis of Toenail

• Registration Number: NCT05260450
• Lead Sponsor: Aalborg University Hospital

Brief Summary

This study aims to assess if laser treatment can cure fungal infection in toenails.

Nail clippings from eligible subjects were obtained and randomised into two groups. All nail clippings were treated once with a 1064 nm Nd:YAG-laser. Before and after treatment, nail clippings were tested for fungal infection by microscopy and by culture.

Detailed Description

This study was carried out as a randomised controlled trial (RCT) including two treatment groups subjected to two different laser treatments. A 1064 nm Nd:YAG-laser (Candela Medical, Ellipse Nordlys (Nd:YAG 1064), USA) was used for all treatments.

Potential subjects were recruited from general practitioners and skin clinics in North Jutland from August 24th, 2021, through December 2021.

All interventions and mycological tests for each subject were performed over the course of one day.

After subjects were included, toenails with a clinical suspicion of onychomycosis (OM) were tested for fungal infection by culture and microscopy. At the same time, nail clippings from said toenails were obtained and randomised into one of two treatment groups, i.e., group A and group B.

The nail clippings were then treated with a 1064 nm Nd:YAG-laser with laser settings as specified by the treatment groups. All nail clippings were treated only once.

Immediately after treatment, nail clippings were again tested for fungal infection by culture and microscopy.

Study Timeline

• Study Start: 2021-10-04
• Primary Completion: 2021-12-06
• Study Completion: 2021-12-06
• Status Verified: 2022-02
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-03-02
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Adult patient (>18 years)
• Clinical suspicion of fungal infection in at least one toenail
• Signed informed consent
• Sufficient nail material to perform two cultures and one nail clipping

Exclusion Criteria

• Administration of oral antifungal medication in the last 12 months or topical antifungal medication in the last month
• Diabetes mellitus with associated peripheral artery disease (PAD) or neuropathy
• Under the influence of alcohol or illegal narcotics
• Unable to understand written and spoken Danish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fungal infection status in nail clippings measured by culture after laser treatment.	Approximately 10 minutes after treatment	The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.
Fungal infection status in nail clippings measured by microscopy before laser treatment.	Approximately 10 minutes before treatment	The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.
Fungal infection status in nail clippings measured by culture before laser treatment.	Approximately 10 minutes before treatment	The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.
Fungal infection status in nail clippings measured by microscopy after laser treatment.	Approximately 10 minutes after treatment	The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.

Secondary Outcome Measures

Name	Time	Method
Nail clippings temperatures	Approximately 2 seconds after end of treatment.	Nail clippings temperature measured at the end of treatment
Fungal infection status in nail clippings measured by PCR before laser treatment.	Approximately 10 minutes before treatment	The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy.
Fungal infection status in nail clippings measured by PCR after laser treatment.	Approximately 10 minutes after treatment	The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy.

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Nordjylland, Denmark