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Completed

NCT Number: NCT05260450

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.

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Key information

Conditions

Onychomycosis of Toenail

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1064 nm Nd:YAG-laser therapy

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.

Primary outcomes

  1. Fungal infection status in nail clippings measured by microscopy after laser treatment.

    Time frame: Approximately 10 minutes after treatment

    The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.

  2. Fungal infection status in nail clippings measured by culture after laser treatment.

    Time frame: Approximately 10 minutes after treatment

    The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.

  3. Fungal infection status in nail clippings measured by microscopy before laser treatment.

    Time frame: Approximately 10 minutes before treatment

    The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.

  4. Fungal infection status in nail clippings measured by culture before laser treatment.

    Time frame: Approximately 10 minutes before treatment

    The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.

Secondary outcomes

  1. Fungal infection status in nail clippings measured by PCR before laser treatment.

    Time frame: Approximately 10 minutes before treatment

    The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy.

  2. Fungal infection status in nail clippings measured by PCR after laser treatment.

    Time frame: Approximately 10 minutes after treatment

    The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy.

  3. Nail clippings temperatures

    Time frame: Approximately 2 seconds after end of treatment.

    Nail clippings temperature measured at the end of treatment

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2022
Registry last updated
Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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