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
- 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.
- 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.
Primary Purpose: Supportive Care
Severity, in terms of pain and itching, as assessed by NCI CTCAE v3.0
Western University of Health Sciences
United States: Federal Government
|St. Joseph Hospital Regional Cancer Center - Orange||Orange, California 92868-3849|
|Hematology Oncology Medical Group of Orange County, Incorporated||Orange, California 92868|
|Western University of Health Sciences||Pomona, California 91766|