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Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream

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. Read our disclaimer for details. Identifier: NCT01349556
Recruitment Status : Withdrawn (Study withdrawn due to volunteer disinterest in participating.)
First Posted : May 6, 2011
Last Update Posted : April 23, 2014
Information provided by (Responsible Party):
Anna Chien, Johns Hopkins University

Brief Summary:

This research is being done to study whether using of topical tretinoin can help prevent the common rash that patients often get while taking epidermal growth factor inhibitor (EGFR-I) medications such ascetuximab or erlotinib.

Patients taking EGFR-I medications often develop skin irritation and acne-like bumps on their face, chest, and other areas. This rash from EGFR-I's is often treated with moisturizers and topical or oral antibiotics. However, there has not yet been a study looking at a way to prevent this common side effect from occurring, and topical tretinoin may be useful in reducing the rash.

Tretinoin 0.025% cream is approved by the Food and Drug Administration (FDA) for the treatment of acne, acne scarring, and photodamage. It is not approved for use in preventing rashes associated with EGFR-I's.

Condition or disease Intervention/treatment Phase
Medication Reaction Drug: Tretinoin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin
Study Start Date : May 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes
Drug Information available for: Tretinoin

Arm Intervention/treatment
Experimental: Tretinoin pre-treatment Drug: Tretinoin
tretinoin 0.025% cream

Primary Outcome Measures :
  1. EGFRi rash severity [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

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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:

  • Age 18 years or over
  • Scheduled to begin treatment with an EGFR inhibitor drug

Exclusion Criteria:

  • Pregnant or nursing
  • History of bleeding disorder
  • History of keloids or large, thick, puffy-looking scars in the last 10 years
  • Used topical retinoids in the last year (e.g. tretinoin/Retin-A, adapalene/Differin, tazarotene/Tazorac)

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): NCT01349556

Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Anna L Chien, MD Johns Hopkins Dermatology
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Responsible Party: Anna Chien, Assistant Professor, Co-Director, Cutaneous Translational Research Program, Johns Hopkins University Identifier: NCT01349556    
Other Study ID Numbers: NA_00042104
First Posted: May 6, 2011    Key Record Dates
Last Update Posted: April 23, 2014
Last Verified: April 2014
Keywords provided by Anna Chien, Johns Hopkins University:
EGFR inhibitors
EGFRi drug rash
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents