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

Primary Purpose

Toenail Onychomycosis, Distal and Lateral Subungual Toenail Onychomycosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aminolevulinic Acid (ALA)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toenail Onychomycosis

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Dermatology at the Whitaker Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Photodynamic Therapy (PDT)

Arm Description

PDT with ALA (photosensitizer) for 3 hours

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 16, 2015
Last Updated
February 3, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
DUSA Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03022903
Brief Title
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Official Title
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
DUSA Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toenail Onychomycosis, Distal and Lateral Subungual Toenail Onychomycosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Photodynamic Therapy (PDT)
Arm Type
Other
Arm Description
PDT with ALA (photosensitizer) for 3 hours
Intervention Type
Procedure
Intervention Name(s)
Aminolevulinic Acid (ALA)
Other Intervention Name(s)
ALA is a topical drug used in the administration of PDT.
Intervention Description
Photosensitizing
Primary Outcome Measure Information:
Title
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
Description
Based on presence of fungal infection from culture assessment
Time Frame
3 weeks after baseline
Title
Number of subjects with clinical cure based on photographs after the 3rd treatment session
Description
Based on visual assessment of photographs: presence or absence of fungal infection
Time Frame
3 weeks after baseline
Secondary Outcome Measure Information:
Title
Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
Time Frame
3 weeks after baseline
Title
Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
Time Frame
24 weeks after first treatment
Title
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time Frame
1 week after baseline
Title
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time Frame
2 weeks after baseline
Title
Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
Time Frame
3 weeks after baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boni E Elewski, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology at the Whitaker Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

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

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