onychomycosis
Conditions
Interventions
intervention group :The target nail plate was irradiated for 15 minutes using the designated light device one hour after application of BIL-1 solution
Sponsors
Shanghai Skin Disease Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Provide a signed and dated informed consent form (ICF). 2. The patient indicates willingness and completes all study procedures and study intervention cycles. 3. Male or female, aged 18–65 years (inclusive). 4. In good general health, diagnosed with onychomycosis according to the Chinese Guidelines for the Diagnosis and Treatment of Onychomycosis (2021 Edition), based on clinical manifestations, positive fungal microscopy, and positive fungal culture. 5. The patient has eligible target fingernail(s) and/or toenail(s) affected by the disease. Target toenails must be the great toe (big toe), while there are no specific requirements for target fingernails. 6. As judged by the investigator, the patient is suitable for systemic drug treatment for onychomycosis. 7. Adequate organ function, including:Liver function: total bilirubin (TBIL) =75 × 10?/L (excluding transfusion-dependent patients), and hemoglobin >=90g/L. 8. For women of childbearing potential: use of highly effective contraception (hormonal, barrier method, or abstinence) for at least 30 days prior to screening, and agreement to use such methods during the study and for 30 days after the end of the study treatment. The blood human chorionic gonadotropin (hCG) pregnancy test result for women of childbearing potential must be negative within 14 days prior to enrollment. During the trial and for at least one month after the end of the study treatment, women of childbearing potential may not donate oocytes, and all male subjects may not donate sperm. 9. For men of childbearing potential: use of condoms or other methods to ensure effective contraception for their partners. 10. No history of alcohol or drug abuse or dependence.
Exclusion criteria
Exclusion criteria: 1.Known history of allergy to BODIPY-class drugs. 2.Have received systemic antifungal treatment within 3 months prior to the start of the study treatment, or topical antifungal treatment targeting the hands, nails, feet, or toenails within 1 month prior to the start of the study treatment. 3.Have received investigational drugs from previous clinical studies within 28 days prior to the start of the study treatment. 4.Have undergone major surgery or experienced significant traumatic injury within 28 days prior to the start of the study treatment, or are scheduled to undergo major surgery during the study period. 5.Have undergone a biopsy or other minor surgical procedures within 7 days prior to the start of the study treatment. 6.Patients with severe primary diseases of the cardio-cerebrovascular, hepatic, renal, or hematopoietic systems, or patients with psychiatric disorders. 7.Females who are pregnant or breastfeeding at the time of screening. 8.Apart from onychomycosis, the patient has any clinically significant condition that, in the investigator's judgment, may interfere with the study evaluation [e.g., the patient has other conditions that may cause clinical nail/toenail abnormalities (such as psoriasis, lichen planus, foot trauma, excessive nail trimming, etc.), has poorly controlled diabetes, has severe peripheral vascular disease, has recurrent cellulitis, lymph insufficiency, is immunocompromised (whether due to an underlying medical condition or immunosuppressive therapy), etc. 9.Currently participating or have participated in another clinical trial within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Onychomycosis Infection Assessment (including: normal area length of the target diseased nail, normal area of the target diseased nail, and percentage of the nail plate involved area to the target diseased nail area);Mycological examination, including direct microscopic examination (fungal microscopy) and fungal culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index (DLQI); | — |
Countries
China
Contacts
Public ContactTai Zongguang
Shanghai Skin Disease Hospital, Tongji University School of Medicine
Outcome results
None listed