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

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

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

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

Conditions
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Toenail Onychomycosis, Distal and Lateral Subungual Toenail Onychomycosis

Intervention / Treatment
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* Procedure: Aminolevulinic Acid (ALA)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Photodynamic Therapy (PDT)<br>PDT with ALA (photosensitizer) for 3 hours | Procedure: Aminolevulinic Acid (ALA)<br>* Photosensitizing<br>* Other names: ALA is a topical drug used in the administration of PDT.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects diagnosed with presence of subungual culture after 3rd treatment session | Based on presence of fungal infection from culture assessment | 3 weeks after baseline | 
| 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 | 3 weeks after baseline | 

Secondary Outcome Measures

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