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

NCT ID: NCT05260450

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2021-12-06

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.

Conditions

Onychomycosis of Toenail

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

1064 nm Nd:YAG-laser therapy

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

1064 nm Nd:YAG-laser therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christian Bisp Sørensen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aalborg University Hospital

Aalborg, North Denmark, Denmark

Countries

Denmark

Other Identifiers

20210020

Identifier Type: -

Identifier Source: org_study_id