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

NCT ID: NCT03022903

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2021-12-31

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.

Conditions

Toenail Onychomycosis; Distal and Lateral Subungual Toenail Onychomycosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Photodynamic Therapy (PDT)

PDT with ALA (photosensitizer) for 3 hours

Group Type: OTHER

Aminolevulinic Acid (ALA)

Intervention Type: PROCEDURE

Photosensitizing

Interventions

Aminolevulinic Acid (ALA)

Photosensitizing

Intervention Type: PROCEDURE

Other Intervention Names

ALA is a topical drug used in the administration of PDT.

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

DUSA Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Boni Elewski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boni E Elewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Dermatology at the Whitaker Clinic

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F150128007

Identifier Type: -

Identifier Source: org_study_id