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Ketoconazole for Cancer-related Rash
Study Summary
This trial is testing ketoconazole to see if it can help treat people with a specific kind of rash caused by EGFR inhibitor therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have a rash or burning skin from EGFR inhibitor treatment.You have had a bad reaction to ketoconazole before.You are allergic or have a bad reaction to sulfites.I will start or continue an EGFR inhibitor treatment for at least 28 days soon.I have filled out the baseline quality of life questionnaire.
- Group 1: Arm I (ketoconazole)
- Group 2: Arm II (placebo)
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there vacancies for enrolment in this research initiative?
"Based on the clinicaltrials.gov website, this research project is recruiting participants at this time. It was first listed on August 22nd 2018 and has been most recently updated on April 13th 2022."
For what illness is Ketoconazole usually prescribed?
"Ketoconazole is a viable option to treat the fungal infections coccidioidomycosis, paracoccidioidomycosis, and tinea corporis caused by trichophyton mentagrophytes."
What are the main aims of this clinical experiment?
"This study will measure the primary outcome of the proportion of patients with improved skin rash over a period of four weeks using Skindex-16. Secondary objectives include an evaluation of changes from baseline in total score and subscales for incidence of skin toxicity as measured by Skin Toxicity Assessment Tool (STAT) and Skindex-16, as well as evaluating any adverse events associated with ketoconazole via Fisher's exact test. Statistical analysis techniques such as t-tests, Wilcoxon rank sum tests, and linear mixed modeling are utilized to compare results between two arms."
Is this research the inaugural study of its kind?
"Initially researched in 2004, sponsored by Sanofi, the first Ketoconazole trial involved 20 participants and was subsequently approved as a medication. Currently there are 10 different ongoing studies for this drug distributed across 3 nations and 23 cities."
Have other researchers explored the possibilities of Ketoconazole?
"First analyzed in 2004 at the Kansas City VAMC, Ketoconazole has been heavily studied since then with 19142 completed trials. There are presently 10 ongoing investigations taking place; of these many studies originate from Saint Paul, Illinois."
In what locales is this medical experiment currently being conducted?
"Patients are being recruited from 8 different clinical trial sites, which include Saint Paul, Urbana and Saint Louis Park. For those interested in partaking in the study it would be wise to select a location close by so that travel is minimized if one decides to enroll."
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