Distal and Lateral Subungual Toenail Onychomycosis Clinical Trial
Official title:
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis
| NCT number | NCT03022903 |
| Other study ID # | F150128007 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | December 2021 |
| Verified date | February 2022 |
| Source | University of Alabama at Birmingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This research study will evaluate the safety and efficacy of using blue light photodynamic therapy (PDT) for treating toenail fungal infections.
| Status | Completed |
| Enrollment | 2 |
| Est. completion date | December 2021 |
| Est. primary completion date | September 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 19 Years to 70 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Dermatology at the Whitaker Clinic | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| University of Alabama at Birmingham | DUSA Pharmaceuticals, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Compare rates of mycological and clinical cure after three treatments between two groups with different ALA incubation times | 3 weeks after baseline | ||
| Secondary | Evaluate the durability of treatment outcomes with subungual culture and photographs at 24 weeks | 24 weeks after first treatment | ||
| Secondary | Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 1 week after baseline | ||
| Secondary | Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 2 weeks after baseline | ||
| Secondary | Evaluate tolerability to treatment using a Visual Analog Scale (VAS) pain scale questionnaire at each treatment visit | 3 weeks after baseline |