A prospective randomized trial of topical pimecrolimus for cetuximab-associated acnelike eruption

Alon Scope, Jocelyn A. Lieb, Stephen W. Dusza, Deborah L. Phelan, Patricia L. Myskowski, Leonard Saltz, Allan C. Halpern*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Background: Clinical trials addressing the acneiform rash associated with epidermal growth factor receptor inhibitors are lacking. Objective: We evaluated the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash. Methods: In all, 24 patients with metastatic colorectal cancer with cetuximab facial rash received twice daily pimecrolimus application for 5 weeks to half of the face. At baseline, week 2, and week 5, a dermatologist performed facial lesion counts, patients reported perceived severity of rash-related symptoms, and standardized facial photographs were obtained for blinded evaluation of global rash severity. Results: Treatment sides had greater decrease in lesion counts than observation sides of face at weeks 2 (P < .001) and 5 (P = .02). However, there were no significant differences in patients' assessment of symptoms and in review of facial photographs for rash severity between treatment and observation sides. Limitations: This study was not placebo controlled. Conclusions: Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.

Original languageEnglish
Pages (from-to)614-620
Number of pages7
JournalJournal of the American Academy of Dermatology
Issue number4
StatePublished - Oct 2009
Externally publishedYes


FundersFunder number
ImClone Systems Inc
Bristol-Myers Squibb
Bristol-Myers Squibb


    • acnelike rash
    • cetuximab
    • clinical trial
    • pimecrolimus


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