Prevention of Drug Rash From Certain Cancer Therapies Using Tretinoin Cream
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Medication Reaction
Intervention: Tretinoin (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): Anna L Chien, MD, Principal Investigator, Affiliation: Johns Hopkins Dermatology
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.
Clinical Details
Official title: Prevention of Epidermal Growth Factor Receptor Inhibitor-Associated Dermatologic Toxicities by Pre-treatment With Topical Tretinoin
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: EGFRi rash severity
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Additional Information
Starting date: May 2011
Last updated: April 21, 2014
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