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

Onychomycosis of Toenail Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260450
• Other study ID #: 20210020
• Status: Completed
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: February 2022
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Onychomycosis
• Onychomycosis of Toenail

Intervention

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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Nordjylland

Sponsors (1)

Lead Sponsor	Collaborator
Aalborg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Nail clippings temperatures	Nail clippings temperature measured at the end of treatment	Approximately 2 seconds after end of treatment.