Use Of Oral Itraconazole In Patients With Locally Limited Basocellular Carcinoma Of Skin.
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|ClinicalTrials.gov Identifier: NCT03972748|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Basal Cell Carcinoma Hedgehog Pathway||Drug: Itraconazole 200 mg||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation Of The Treatment With Oral Itraconazole In Patients With Basocellular Carcinoma Of Skin, Locally Limited Disease.|
|Actual Study Start Date :||January 5, 2018|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||June 1, 2021|
Oral Itraconazole capsules, 200 mg
Drug: Itraconazole 200 mg
Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.
- clinical response [ Time Frame: 60 days ]tumor area response registered through dermatologic evaluation
- hedgehog pathway activity [ Time Frame: 60 days ]Measured through the Ki67 index on pathological specimens at the beginning and at the end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03972748
|Contact: Renato M Bakos, Ph. D.||+555133598000 ext email@example.com|
|Contact: Rodrigo P Pereira, M.D.||+555133598000 ext firstname.lastname@example.org|
|Hospital de Clínicas de Porto Alegre||Recruiting|
|Porto Alegre, RS, Brazil, 90035903|
|Contact: Renato M Bakos, Ph.D. +555133598000 ext 8619 email@example.com|
|Study Chair:||Renato M Bakos, Ph. D.||Hospital de Clinicas de Porto Alegre|