Exploring Different Dose-frequency Home Photodynamic Therapy Protocols Using a Novel Home-targeted LED Device for Onychomycosis, a Randomized Feasibility Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for onychomycosis, using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. Efficacy will be assessed by mycologic
研究概览
简要总结
This randomized feasibility trial aims to determine the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) using a novel LED device (L-Home PhoD) for the treatment of onychomycosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with onychomycosis (nail fungal infection) by a dermatologist.
- •Diagnosis criteria include at least one clinical criterion combined with at least one laboratory examination criterion.
- •Clinical Criteria:
- •Discoloration patches/streaks on the nail.
- •Onycholysis (nail separation from the nail bed).
- •Subungual hyperkeratosis/debris (thickening under the nail).
- •Nail plate thickening.
- •Laboratory Examination Criteria:
- •Direct microscopy using KOH preparation.
- •Histopathological examination using Periodic Acid Schiff (PAS) stain.
- •Patients with distal lateral subungual onychomycosis (DLSO) of the fingernails or toenails, except for the little toenail.
- •Patients with onychomycosis who have limitations on or refuse oral antifungal treatment.
- •Individuals willing to participate in the research after receiving a full explanation of the research details, able to comply with the research procedures, and have signed the informed consent form.
排除标准
- •Presence of nail abnormalities caused by other diseases or conditions.
- •Pregnant or breastfeeding.
- •History of receiving oral antifungal agents within the past 6 months or topical antifungal agents within the past 1 month prior to enrollment.
- •History of photosensitivity or photodermatitis.
- •Known allergy to methylene blue.
- •Presence of erythematous or oedematous inflammatory skin conditions near the site of onychomycosis.
- •Severe peripheral arterial disease.
- •Uncontrolled diabetes mellitus or HbA1C > 8%.
- •Immunocompromised status, such as HIV infection with CD4 count < 200 cells/mm³ or diagnosis of Acquired Immunodeficiency Syndrome (AIDS).
- •Current use of immunosuppressive medications, including Tacrolimus, Azathioprine, Cyclosporine, Mycophenolate mofetil, or Prednisolone >10 mg/day.
研究组 & 干预措施
PDT_160BIW
Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: Photodynamic Therapy with Conventional Methylene Blue (Radiation)
PDT_160BIW
Twice a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: urea 40% cream (Drug)
PDT_160OIW
once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: Photodynamic Therapy with Conventional Methylene Blue (Radiation)
PDT_160OIW
once a week of MB-PDT at 160/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: urea 40% cream (Drug)
PDT_120BIW
Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: Photodynamic Therapy with Conventional Methylene Blue (Radiation)
PDT_120BIW
Twice a week of MB-PDT at 120/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: urea 40% cream (Drug)
PDT_80BIW
Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: Photodynamic Therapy with Conventional Methylene Blue (Radiation)
PDT_80BIW
Twice a week of MB-PDT at 80/cm2 and 40%Urea cream with occlusion before MB-PDT
干预措施: urea 40% cream (Drug)
NonPDT
40%Urea cream with occlusion
干预措施: urea 40% cream (Drug)
结局指标
主要结局
To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for onychomycosis, using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit. Efficacy will be assessed by mycologic
时间窗: 12 weeks
次要结局
- To evaluate the optimal light energy dose and treatment frequency for home-based photodynamic therapy (hPDT) for the treatment of onychomycosis. Efficacy will be assessed by changes in the dermoscopic Onychomycosis Severity Index (d-OSI)(12 weeks)
- To evaluate the feasibility of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit(12 weeks)
- To assess the safety of home-based photodynamic therapy (hPDT) for the treatment of onychomycosis using the L-Home PhoD device in combination with the KCMH Methylene Blue-Home Nail Kit.(12 weeks)
研究者
Einapak Boontaveeyuwat, MD
Asst. Prof
Chulalongkorn University