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Search / Trial NCT03972748

Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.

Launched by HOSPITAL DE CLINICAS DE PORTO ALEGRE · May 31, 2019

Trial Information

Current as of July 23, 2025

Unknown status

Keywords

Itraconazole

ClinConnect Summary

Patients with localized basocellular carcinoma of the skin, will receive oral Itraconazole, 200 mg once daily, for 60 days, before surgery with curative intent.

Tumor area regression will be measured through dermatologic evaluation and photographic documentation on baseline and at the end of the 60 day treatment period.

The activity of the Hedgehog pathway will be measured on tissue samples obtained at the time of diagnosis and at the time of curative intent surgery, through the measuring of the Ki67 index.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients with diagnosis of Basocellular Carcinoma (BCC) of the Skin, histologically confirmed.
  • At least one BCC lesion with 10 mm in the longest diameter
  • Disease amenable to surgical intervention with curable intent.
  • Signed Informed Consent
  • PS ECOG 0 to 3
  • Exclusion Criteria:
  • Chronic renal disease, with a glomerular filtration rate of less than 30 ml/min
  • Acute or chronic liver disease, as measured by: total bilirubin \> than 1.5 x ULN and AST and ALT \> than 5 x ULN.
  • Symptomatic cardiac insufficiency or an ejection fraction lower than 50% measured through echocardiography,
  • Other active malignancies in the last year.
  • Uncontrolled systemic hypertension,
  • Any chronic infections such as tuberculosis, viral hepatitis and HIV.
  • Pregnancy, suspected or confirmed.
  • Known intolerance to the use of Itraconazole.

About Hospital De Clinicas De Porto Alegre

Hospital de Clínicas de Porto Alegre (HCPA) is a leading academic medical center in Brazil, renowned for its commitment to advancing healthcare through innovative clinical research. As a sponsor of clinical trials, HCPA leverages its extensive expertise in various medical disciplines to conduct rigorous studies aimed at improving patient outcomes and contributing to the global medical community. With a multidisciplinary team of skilled professionals and state-of-the-art facilities, HCPA fosters a collaborative environment that prioritizes ethical standards, patient safety, and scientific integrity in all its research endeavors.

Locations

Porto Alegre, Rs, Brazil

Patients applied

0 patients applied

Trial Officials

Renato M Bakos, Ph. D.

Study Chair

Hospital de Clinicas de Porto Alegre

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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