NCT05260450

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Aalborg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-10-04
• Primary completion: 2021-12-06
• Completion: 2021-12-06
• First posted: 2022-03-02
• Last updated: 2022-03-02

Locations

1 site across 1 country: Denmark

Regulatory

• FDA-regulated device study