Pulsed Dye Laser Treatment of Onychomycosis

This study is currently recruiting participants.
Verified February 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01915355
First received: July 29, 2013
Last updated: February 4, 2014
Last verified: February 2014
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    After 3 laser treatments, the subject should experience clinical clearance.


Estimated Enrollment: 10
Study Start Date: July 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01915355

Contacts
Contact: Jefferson Dermatology 215-955-6680

Locations
United States, Pennsylvania
Jefferson Dermatology Associates Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Jefferson Dermatology    215-955-6680      
Sub-Investigator: Joya Sahu, MD         
Principal Investigator: Nazanin Saedi, MD         
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Nazanin Saedi, MD Jefferson Dermatology Associates
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01915355     History of Changes
Other Study ID Numbers: IRB 13D.230
Study First Received: July 29, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014