A Study of Topical Steroids as Preemptive Therapy for EGFR Inhibitor-Induced Papulopustular Eruption



Status:Recruiting
Conditions:Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:February 16, 2017
End Date:December 2019
Contact:Dermatology CTU
Email:NUOncoderm@northwestern.edu
Phone:312-503-5944

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A Randomized Phase II Study of Topical Steroids as Preemptive Therapy for Epidermal Growth Factor Receptor Inhibitor-Induced Papulopustular Eruption

This randomized, controlled, phase II clinical study is designed to assess the efficacy of
preemptive treatment with topical steroids in preventing the papulopustular eruption induced
by epidermal growth factor receptor inhibitor (EGFRI) treatment in cancer patients.
Participants will be followed up for 6 weeks of twice daily application of triamcinolone
cream to the face, chest, and back.


Inclusion Criteria:

- Patients must have a histologically or cytologically confirmed cancer diagnosis for
which EGFRI treatment is indicated

- Initiation of topical steroids or control treatment within 3 days of initiation of
cetuximab, erlotinib, panitumumab, or afatinib

- Patients must be age ≥ 18 years.

- Life expectancy of greater than 6 weeks

- Patient able to use topical medications reliably and complete questionnaires with
assistance if needed

- Patients must have the ability to understand and the willingness to sign a written
informed consent prior to registration on study.

Exclusion Criteria:

- Patients who have used systemic or topical steroids within 7 days of trial
registration, or start systemic or topical steroids for reasons unrelated to trial
during the 6-week follow up period

- Patients who have used antibiotics within 7 days of trial registration, or start
antibiotics for other conditions during the 6-week follow up period

- History of allergic reactions to topical steroids

- Patients with any rash at the time of study registration

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patients using any other topical medications in the treatment areas (face, chest, or
back).
We found this trial at
1
site
Chicago, Illinois 60611
Principal Investigator: Jennifer Choi, MD
Phone: 312-503-5944
?
mi
from
Chicago, IL
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