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

Not Applicable

Completed

• Conditions: Toenail Onychomycosis; Distal and Lateral Subungual Toenail Onychomycosis
• Interventions: Procedure: Aminolevulinic Acid (ALA)

• Registration Number: NCT03022903
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-16
• Study First Submitted QC: 2017-01-17
• Study First Posted: 2017-01-18
• Primary Completion: 2019-09
• Study Completion: 2021-12
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-03
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Photodynamic Therapy (PDT)	Aminolevulinic Acid (ALA)	PDT with ALA (photosensitizer) for 3 hours

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	3 weeks after baseline
Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times	3 weeks after baseline

Trial Locations

Locations (1)

Dermatology at the Whitaker Clinic; 🇺🇸 Birmingham, Alabama, United States