Clinical trial NCT03022903: Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Official title: Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Toenail Onychomycosis
Distal and Lateral Subungual Toenail Onychomycosis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: DUSA Pharmaceuticals, Inc.
First posted: 2017-01-18
Enrollment: 2
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
timeFrame: 3 weeks after baseline
measure: Number of subjects with clinical cure based on photographs after the 3rd treatment session
timeFrame: 3 weeks after baseline
Secondary outcomes:
measure: Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times
timeFrame: 3 weeks after baseline
measure: Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks
timeFrame: 24 weeks after first treatment
measure: Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
timeFrame: 1 week after baseline
measure: Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
timeFrame: 2 weeks after baseline
measure: Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit
timeFrame: 3 weeks after baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Dermatology at the Whitaker Clinic
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Boni E Elewski, MD
role: PRINCIPAL_INVESTIGATOR
References: