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Pulsed Dye Laser Treatment of Onychomycosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01915355
First Posted: August 2, 2013
Last Update Posted: August 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Thomas Jefferson University
  Purpose

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.


Condition Intervention
Onychomycosis Device: Pulsed Dye Laser for the treatment of nail fungus

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pulsed Dye Laser Treatment of Onychomycosis

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Total Nail Clearance [ Time Frame: approximately 12 weeks ]
    After 3 laser treatments, the subject should experience clinical clearance.


Enrollment: 11
Study Start Date: July 2013
Study Completion Date: July 2015
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: 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.

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915355


Locations
United States, Pennsylvania
Jefferson Dermatology Associates
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Nazanin Saedi, MD Jefferson Dermatology Associates
  More Information

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01915355     History of Changes
Other Study ID Numbers: IRB 13D.230
First Submitted: July 29, 2013
First Posted: August 2, 2013
Last Update Posted: August 19, 2016
Last Verified: August 2016

Keywords provided by Thomas Jefferson University:
onychomycosis
nail
fungus

Additional relevant MeSH terms:
Onychomycosis
Tinea
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Nail Diseases
Skin Diseases


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