Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT05260450
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2022-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Sponsor:
Aalborg University Hospital
Organization:
Study Overview
Official Title:
Laser Treatment of Toenail Onychomycosis With a 1064 nm Nd:YAG-laser
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: