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

Primary Purpose

Onychomycosis of Toenail

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
1064 nm Nd:YAG-laser therapy
Sponsored by
Aalborg University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Onychomycosis of Toenail

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aalborg University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (Long-pulsed group)

Group B (Short-pulsed group)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Fungal infection status in nail clippings measured by PCR before laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy.
Fungal infection status in nail clippings measured by PCR after laser treatment.
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy.
Nail clippings temperatures
Nail clippings temperature measured at the end of treatment

Full Information

First Posted
February 9, 2022
Last Updated
February 18, 2022
Sponsor
Aalborg University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05260450
Brief Title
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Official Title
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Onychomycosis of Toenail

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (Long-pulsed group)
Arm Type
Experimental
Arm 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.
Arm Title
Group B (Short-pulsed group)
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
1064 nm Nd:YAG-laser therapy
Intervention Description
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 Outcome Measure Information:
Title
Fungal infection status in nail clippings measured by microscopy after laser treatment.
Description
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy after therapy.
Time Frame
Approximately 10 minutes after treatment
Title
Fungal infection status in nail clippings measured by culture after laser treatment.
Description
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture after therapy.
Time Frame
Approximately 10 minutes after treatment
Title
Fungal infection status in nail clippings measured by microscopy before laser treatment.
Description
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by microscopy before therapy.
Time Frame
Approximately 10 minutes before treatment
Title
Fungal infection status in nail clippings measured by culture before laser treatment.
Description
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by culture before therapy.
Time Frame
Approximately 10 minutes before treatment
Secondary Outcome Measure Information:
Title
Fungal infection status in nail clippings measured by PCR before laser treatment.
Description
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR before therapy.
Time Frame
Approximately 10 minutes before treatment
Title
Fungal infection status in nail clippings measured by PCR after laser treatment.
Description
The number (rate) of included nail clippings in each group that were found negative for fungal infection measured by PCR after therapy.
Time Frame
Approximately 10 minutes after treatment
Title
Nail clippings temperatures
Description
Nail clippings temperature measured at the end of treatment
Time Frame
Approximately 2 seconds after end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
Nordjylland
ZIP/Postal Code
9000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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