NCT05415852

Brief Summary

Onychomycosis is the most common nail disease, representing more than 50% of all onychopathies. Future studies on the absorption spectra of dermatophyte fungi will be needed to develop lasers that effectively exploit absorption differences in fungi and dermal tissue.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

June 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

3 months

First QC Date

May 20, 2022

Last Update Submit

June 8, 2022

Conditions

Onychomycosis

Outcome Measures

Primary Outcomes (1)

  • Onychomycosis severity index

    clinical assessment

    change from baseline at 3 months

Study Arms (4)

fractional CO2 laser

ACTIVE COMPARATOR

Laser

Device: Laser

Pulsed dye laser

ACTIVE COMPARATOR

Laser

Device: Laser

Nd Yag

ACTIVE COMPARATOR

Laser

Device: Laser

Q switched Nd Yag

ACTIVE COMPARATOR

Laser

Device: Laser

Interventions

LaserDEVICE

Laser

Nd YagPulsed dye laserQ switched Nd Yagfractional CO2 laser

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with onychomycosis.

You may not qualify if:

  • Patients with excessive manual work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Onychomycosis

Interventions

Lasers

Condition Hierarchy (Ancestors)

TineaDermatomycosesMycosesBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousNail DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 20, 2022

First Posted

June 13, 2022

Study Start

June 25, 2022

Primary Completion

September 15, 2022

Study Completion

September 15, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06