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.

• The study reported on a sample of 16 patients with metastatic colorectal cancer.
• Patients were aged 18 years or older.
• Gender was not reported.

• Single site
• Outpatient
• New York City Hospital in New York

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.

• Baseline evaluation    
• Skin assessment by dermatology
• Digital photography of faces
• Clinical and skin assessment at weeks 2, 5, and 7
• Counts of facial lesions at weeks 2, 5, and 7
• Patient-completed daily study diary

• A statistically significantly greater decrease in lesion counts existed for the treatment versus observational sides of patients' faces by week 2. This result was maintained by week 5, but was nonsignificant after stopping cream by week 7.
• No significant differences existed in rash severity.
• No difference existed in the frequency of patient-assessed itch, burning, and dryness or perceived degree of facial erythema between treated and untreated sides of the face, per patients’ report.
• Of note, a bilateral decrease in rash severity was reported at week 7.

Pimecrolimus application did not translate into clinically significant benefit in patients with cetuximab-related facial rash.

• The sample size was small (fewer than 30 patients).
• The study was not placebo controlled.

Rash may improve without interventions.