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

Aalborg University Hospital

Status: Completed

Conditions: Onychomycosis of Toenail

Treatments: Device: 1064 nm Nd:YAG-laser therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05260450

20210020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Group A (Long-pulsed group)

Experimental group

Description:

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.

Treatment:

Device: 1064 nm Nd:YAG-laser therapy

Group B (Short-pulsed group)

Active Comparator group

Description:

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.

Treatment:

Device: 1064 nm Nd:YAG-laser therapy