Scope, A., Lieb, J.A., Dusza, S.W., Phelan, D.L., Myskowski, P.L., Saltz, L., & Halpern, A.C. (2009). A prospective randomized trial of topical pimecrolimus for cetuximab-associated acnelike eruption. Journal of the American Academy of Dermatology, 61, 614–620.
To determine the ability of topical pimecrolimus to reduce the severity of cetuximab-related facial rash.
Patients aged 18 years or older with metastatic colorectal cancer who were on cetuximab treatment and experienced a rash were eligible for randomization. Open-label pimecrolimus 1% cream was to be applied to one side of the face BID for five weeks. Patients completed a daily dairy. Physicians queried patients about side effects and compliance during study visits. Complete skin examinations were performed by dermatologists who were blinded to study applications. Digital photos were used for review. Patients were asked about the presence and perceived severity of rash-associated symptoms on either side of the face. Counts of facial lesions on both sides of the face were performed by blinded dermatologists at weeks 2, 5, and 7. The study took place over five weeks.
Patients were undergoing the active treatment phase of care.
This was a single-blind, randomized, prospective clinical trial, with patients used as their own controls.
Pimecrolimus application did not translate into clinically significant benefit in patients with cetuximab-related facial rash.
Rash may improve without interventions.