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

NCT03022903 | Completed

• 1 other identifier: F150128007
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Toenail Onychomycosis; Distal and Lateral Subungual Toenail Onychomycosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Photodynamic Therapy (PDT)

OTHER

PDT with ALA (photosensitizer) for 3 hours

Procedure: Aminolevulinic Acid (ALA)

Interventions

Aminolevulinic Acid (ALA) PROCEDURE

Photosensitizing

Also known as: ALA is a topical drug used in the administration of PDT.

Photodynamic Therapy (PDT)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• DUSA Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Dermatology at the Whitaker Clinic

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Interventions

Aminolevulinic Acid

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Boni E Elewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: January 18, 2017
• Study Start: September 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: December 1, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

US (1)