Pulsed Dye Laser Treatment of Onychomycosis

NCT ID: NCT01915355

Last Updated: 2016-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2015-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, or nail fungus.

Hypothesis: Complete nail clearance will occur in approximately half of patients after 3 laser treatments.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

10 patients will participate nationally. The investigators hope to enroll all 10 patients at Jefferson. Involvement in the study will last about 8-12 weeks for the subject. The entire study will take about 12 months to complete.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Onychomycosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pulsed Dye Laser for fungus treatment

The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.

Group Type EXPERIMENTAL

Pulsed Dye Laser for the treatment of nail fungus

Intervention Type DEVICE

The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pulsed Dye Laser for the treatment of nail fungus

The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Ages 18-65 years old
* Diagnosis of onychomycosis based on positive fungal culture for dermatophyte and positive PAS from toenail clipping

Exclusion Criteria

* HIV/immunosuppression
* Candidal toenail infection
* Prior PO antifungal therapy within last 6 months
* Personal history of psoriasis, lichen planus, or significant photosensitivity disorder
* Any serious generalized medical condition
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nazanin Saedi, MD

Role: PRINCIPAL_INVESTIGATOR

Jefferson Dermatology Associates

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Jefferson Dermatology Associates

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB 13D.230

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiofrequency in Onychomycosis
NCT05390190 UNKNOWN NA