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

Abstract

Clinical trials addressing the acneiform rash associated with epidermal growth factor receptor inhibitors are lacking. We evaluated the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash. 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. 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. This study was not placebo controlled. Pimecrolimus application did not translate into clinically meaningful benefit for patients with cetuximab-related facial rash.