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

NCT05260450 | Completed FDA Device

• 1 other identifier: 20210020
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Onychomycosis of Toenail

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (3)

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

  Approximately 10 minutes before treatment

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

  Approximately 10 minutes after treatment

• Nail clippings temperatures

  Approximately 2 seconds after end of treatment.

Study Arms (2)

Group A (Long-pulsed group)

EXPERIMENTAL

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.

Device: 1064 nm Nd:YAG-laser therapy

Group B (Short-pulsed group)

ACTIVE COMPARATOR

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.

Device: 1064 nm Nd:YAG-laser therapy

Interventions

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.

Group A (Long-pulsed group); Group B (Short-pulsed group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, North Denmark, 9000, Denmark

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 2, 2022
• Study Start: October 4, 2021
• Primary Completion: December 6, 2021
• Study Completion: December 6, 2021
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)