Pulsed Dye Laser Treatment of Onychomycosis

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.

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Key information

Conditions

Onychomycosis Bacterial Infections and Mycoses Dermatomycoses Infections Mycoses Nail Diseases Skin Diseases Skin Diseases, Infectious Skin and Connective Tissue Diseases Tinea

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jefferson Dermatology Associates

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed Dye Laser for the treatment of nail fungus

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.

Primary outcomes

Total Nail Clearance

Time frame: approximately 12 weeks

After 3 laser treatments, the subject should experience clinical clearance.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Aug 2, 2013
Registry last updated: Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed