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Recruitment Status : Withdrawn (Study withdrawn due to volunteer disinterest in participating.)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

May 5, 2011
May 6, 2011
April 23, 2014
May 2011
March 2014   (Final data collection date for primary outcome measure)
EGFRi rash severity [ Time Frame: 8 weeks ]
Same as current
Complete list of historical versions of study NCT01349556 on Archive Site
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Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin

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.

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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Medication Reaction
Drug: Tretinoin
tretinoin 0.025% cream
Experimental: Tretinoin pre-treatment
Intervention: Drug: Tretinoin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
March 2014
March 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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United States
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Anna Chien, Johns Hopkins University
Johns Hopkins University
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Principal Investigator: Anna L Chien, MD Johns Hopkins Dermatology
Johns Hopkins University
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP