Regenecare® Wound Gel in Treating Rash in Patients Receiving Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer

2014-08-27 03:38:50 | BioPortfolio


RATIONALE: Regenecare® wound gel may help lessen pain and itching in patients who develop a rash while undergoing treatment with epidermal growth factor receptor inhibitor therapy for cancer.

PURPOSE: This clinical trial is studying how well Regenecare® wound gel works in treating rash in patients receiving epidermal growth factor receptor inhibitor therapy for cancer.




- 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.

Study Design

Primary Purpose: Supportive Care


Dermatologic Complications


collagen/aloe vera/vitamin E/lidocaine topical hydrogel, clinical observation, questionnaire administration, quality-of-life assessment


Hematology Oncology Medical Group of Orange County, Incorporated
United States




National Cancer Institute (NCI)

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:38:50-0400

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