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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03115567
Recruitment Status : Recruiting
First Posted : April 14, 2017
Last Update Posted : February 5, 2019
Information provided by (Responsible Party):
Jennifer Nam Choi, MD, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acneiform Rash Papulopustular Eruption Drug: Triamcinolone Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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 : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
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.
Experimental: Triamcinolone
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.
Drug: Triamcinolone
6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.

Primary Outcome Measures :
  1. % 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

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 identifier (NCT number): NCT03115567

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Contact: Dermatology CTU 312-503-5944

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United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology Recruiting
Chicago, Illinois, United States, 60611
Contact: Dermatology CTU    312-503-5944   
Principal Investigator: Jennifer Choi, MD         
Sponsors and Collaborators
Northwestern University
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Principal Investigator: Jennifer N Choi, MD Northwestern University
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Responsible Party: Jennifer Nam Choi, MD, Chief of Oncodermatology, Northwestern University Identifier: NCT03115567    
Other Study ID Numbers: JNC06142016
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs