Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis

Overview

This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2019

Detailed Description

This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.

Interventions

  • Procedure: Aminolevulinic Acid (ALA)
    • Photosensitizing

Arms, Groups and Cohorts

  • Other: Photodynamic Therapy (PDT)
    • PDT with ALA (photosensitizer) for 3 hours

Clinical Trial Outcome Measures

Primary Measures

  • Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
    • Time Frame: 3 weeks after baseline
    • Based on presence of fungal infection from culture assessment
  • Number of subjects with clinical cure based on photographs after the 3rd treatment session
    • Time Frame: 3 weeks after baseline
    • Based on visual assessment of photographs: presence or absence of fungal infection

Secondary Measures

  • Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
    • Time Frame: 3 weeks after baseline
  • Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
    • Time Frame: 24 weeks after first treatment
  • Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
    • Time Frame: 1 week after baseline
  • Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
    • Time Frame: 2 weeks after baseline
  • Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
    • Time Frame: 3 weeks after baseline

Participating in This Clinical Trial

Inclusion Criteria

  • Patients older than 19 and younger than 70 years – Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI) – Diagnosed with distal lateral subungual onychomycosis (DLSO) of the great toe with both positive potassium hydroxide (KOH) and positive culture growth of Trichophyton rubrum – No topical treatment for DLSO in the preceding 2 weeks and no oral treatment for DLSO (itraconazole or terbinafine) in the preceding 8 weeks – At lease 20% of target great toe nail affected Exclusion Criteria:

  • Unable to comply with the protocol (as defined y the investigator; i.e. drug or alcohol abuse or history of noncompliance) – Patients with active nail disease that would confound evaluation of DLSO, such as psoriasis – Patients with greater than 6 toenails affected – Over 90% of target great toe affected – Evidence of fingernail fungal infection – Patients with recurrent serious infections or have been hospitalized in the preceding 6 months for infection – Patients with known history of HIV or hepatitis B or C infection – Patients with severe, progressive, or uncontrolled with renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurologic disease – Any subject who, in the opinion of the investigator, will be uncooperative or unable to comply with study procedures

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Alabama at Birmingham
  • Collaborator
    • DUSA Pharmaceuticals, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Boni Elewski, Principal Investigator – University of Alabama at Birmingham
  • Overall Official(s)
    • Boni E Elewski, MD, Principal Investigator, University of Alabama at Birmingham

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