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

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

Study Overview

• Status: Completed
• Conditions: Toenail Onychomycosis; Distal and Lateral Subungual Toenail Onychomycosis
• Intervention / Treatment: Procedure: Aminolevulinic Acid (ALA)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • Dermatology at the Whitaker Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: DUSA Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: January 17, 2017
• First Posted (Estimate): January 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 3, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: F150128007