A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption
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|ClinicalTrials.gov Identifier: NCT03115567|
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : March 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acneiform Rash Papulopustular Eruption||Drug: Triamcinolone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
No Intervention: Control
Patients in Control group will be instructed to follow a daily moisturizer and sunscreen regimen. Erlotinib, cetuximab, panitumumab, or afatinib will be administered as standard of care treatment.
Patients in the Triamcinolone group will be applying Triamcinolone 0.1% cream daily to their face, chest, and upper back, in addition to adhering to the same daily moisturizer and sunscreen regimen of the Control group. Erlotinib, cetuximab, panitumumab, or afatinib will be administered concomitantly as standard of care treatment.
6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
- % of participants with grade 2 rash or higher [ Time Frame: 6 weeks ]To assess the difference in percentage of participants who develop a grade 2 or greater rash in the control group as compared to the case group of preemptive treatment with topical steroids (triamcinolone 0.1% cream for application to face, chest and back) when administered concomitantly for 6 weeks with erlotinib, cetuximab, panitumumab, or afatinib to prevent papulopustular eruptions.
- Difference in rash severity using the NCI-CTCAE 4.03 grading criteria [ Time Frame: 6 weeks ]To assess the difference in maximum severity of rash between the preemptive treatment group and the reactive treatment group.
- Concordance of rash grading between NCI-CTCAE and Lacouture grading scale [ Time Frame: 6 weeks ]To assess the concordance of rash severity grading between the NCI-CTCAE grading system (grade 1-5 ) and those of Lacouture et al. (1a, 1b, 2a, 2b, 3a,3b), and global rash severity (grade 1-3) based on photographic analysis.
- Change in quality of life using FACT-EGFRI 18 quality of life assessment [ Time Frame: 6 weeks ]To assess the difference in change in quality-of-life due to rash between the two treatment groups.
- Number of participants in the treatment and control group who adhere to their chemotherapy regimen determined by whether patients discontinue their chemotherapy regimen or continue their full course of treatment [ Time Frame: 6 weeks ]This measure is to determine if the control group discontinues their chemotherapy regimen more often than the treatment group
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): NCT03115567
|Contact: Linda Serrano, MD||312-503-5903||NUOncoderm@northwestern.edu|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine, Department of Dermatology||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Linda Serrano, MD 312-503-5903 NUOncoderm@northwestern.edu|
|Principal Investigator: Jennifer Choi, MD|
|Principal Investigator:||Jennifer N Choi, MD||Northwestern University|