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

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.

Study Overview

• Status: Completed
• Conditions: Onychomycosis of Toenail
• Intervention / Treatment: Device: 1064 nm Nd:YAG-laser therapy

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Nordjylland
    • Aalborg, Nordjylland, Denmark, 9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Long-pulsed group); Nail clippings allocated to group A received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 10 ms, spot size 3 mm, fluence 40-50 J/cm2, number of laser pulses 100 /cm2.	Device: 1064 nm Nd:YAG-laser therapy; 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 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.
Active Comparator: Group B (Short-pulsed group); Nail clippings allocated to group B received laser treatment with a 1064 nm Nd:YAG-laser. They received one treatment with laser settings: pulse duration 0.3 ms, spot size 3 mm, fluence 40 J/cm2, number of laser pulses 100 /cm2.	Device: 1064 nm Nd:YAG-laser therapy; 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 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): December 6, 2021

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: 20210020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes