Trial Information

A Pilot Cross-Over Study to Evaluate the Use of Regenecare™ Topical Gel in Patients With Cutaneous Toxicity Caused by Epidermal Growth Factor Receptor (HER1/EGFR) Inhibitors

OBJECTIVES:

Primary

- Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in
patients who develop an acneform rash while undergoing treatment with human epidermal
receptor 1 (HER1)/epidermal growth factor receptor (EGFR) inhibitor therapy for cancer.

Secondary

- Determine the tolerability of this drug in these patients.

- Determine satisfaction of these patients with this drug.

OUTLINE: This is a pilot, prospective, study.

- Observation: Patients undergo facial evaluation by full-face photography (i.e., camera
lens 12-18 inches from the face) prior to development of skin rash (baseline). Patients
then self-monitor for the appearance of acneform skin rash while undergoing concurrent
cancer therapy. Upon initial onset of rash, patients are re-evaluated. Patients with
grade 2 skin rash proceed to treatment.

- Treatment: Patients apply topical Regenecare® wound gel to the right side of the face ≥
4 times daily. After 1 week of treatment, patients apply the gel to both sides of the
face. Treatment continues for ≥ 6 weeks in the absence of unacceptable toxicity or
until the rash disappears.

Patients are evaluated weekly by facial examination, full-face photography, clinical
symptoms self-reported in a patient diary, and questionnaires measuring patient satisfaction
and quality of life.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.