Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis (NCT03022903) | Clinical Trial Compass
CompletedNot Applicable
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
United States2 participantsStarted 2015-09
Plain-language summary
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
Who can participate
Age range19 Years – 70 Years
SexFEMALE
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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
What they're measuring
1
Number of subjects diagnosed with presence of subungual culture after 3rd treatment session
Timeframe: 3 weeks after baseline
2
Number of subjects with clinical cure based on photographs after the 3rd treatment session