NIPH Clinical Trials Search

Clinical Trial of Neoadjuvant Itraconazole Therapy for Basal Cell Carcinoma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Basal cell carcionoma
Date of first enrollment	17/02/2026
Target sample size	12
Countries of recruitment
Study type	Interventional
Intervention(s)	Patients with basal cell carcinoma scheduled for surgical excision and who have a concomitant cutaneous fungal infection will receive itraconazole 200 mg once daily, administered immediately after a meal. After 30 to 50 days of continuous treatment from the start of the study, patients will return for an evaluation of changes in lesion size from baseline and for blood tests to assess potential adverse effects.If no serious adverse events attributable to itraconazole are observed, no increase is noted in either the long or short axis of the lesion, and the treating physician determines that continuation is appropriate, treatment will be continued. Subsequently, depending on the patient's availability and operating room scheduling, surgical excision of the lesion will be performed within 30 days.

Outcome(s)

Primary Outcome

The rate of change (percentage reduction) in lesion area from baseline to Days 30-50 after initiating oral administration of itraconazole.

Secondary Outcome

The percent change in lesion area at the time of surgery, using the start of oral administration as baseline. The rate of negative surgical margins on histopathological examination. The proportion of Ki-67-positive tumor cells. The frequency and proportion of adverse events or relevant conditions, and the treatment continuation and discontinuation rates. The correlation between the reduction rate of the lesion and (1) the proportion of immune cells infiltrating the tumor, (2) molecular expression profiles of tumor cells, and (3) somatic gene mutations.

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	Eligible patients must meet all of the following criteria: Patients who (i) have a dermatophytic infection, cutaneous candidiasis, or other fungal skin infection for which oral itraconazole treatment is indicated, and (ii) have been diagnosed with basal cell carcinoma and are scheduled to undergo surgical excision. Patients with multiple basal cell carcinomas may be included, and the therapeutic effect on each lesion will be evaluated separately. Male or female patients aged 18 years or older at the time of obtaining consent. Patients who are able to attend scheduled visits in accordance with the study schedule. Patients who, after receiving a thorough explanation of this study, have fully understood the information and have provided written informed consent of their own free will.
Exclude criteria	Patients who meet any of the following criteria will be excluded from the study: Patients with current or past history of congestive heart failure. Patients who have had renal dysfunction (serum creatinine >= 1.6 mg/dL) within the 3 months prior to the date of informed consent. Patients who have had hepatic dysfunction within the 3 months prior to the date of informed consent (serum T-bil >= 1.5 mg/dL or ALT >= 100 IU/L) and are receiving colchicine. Patients who have had severe hepatic disease within the 3 months prior to the date of informed consent (serum T-bil >= 3 mg/dL or ALT >= 150 IU/L). Patients who are pregnant, may become pregnant during the study period, or are breastfeeding. Patients who are concomitantly receiving any of the following medications: Azelnidipine; Azelnidipine/Olmesartan Medoxomil; Anamorelin Hydrochloride; Aliskiren; Isavuconazonium Sulfate; Ivabradine; Ibrutinib; Eplerenone; Ergotamine/Caffeine/Isopropylantipyrine; Ergometrine; Quinidine; Simvastatin; Sildenafil; Dihydroergotamine; Suvorexant; Tadalafil; Ticagrelor; Triazolam; Nisoldipine; Finerenone; Vardenafil; Blonanserin; Venetoclax; Bepridil; Voclosporin; Pimozide; Methylergometrine; Lurasidone Hydrochloride; Rivaroxaban; Lomitapide; Pimozide. Patients deemed inappropriate for participation in the study by the principal investigator or a co-investigator.