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

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

Summary

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.

Description

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.

Study Design

Primary Purpose: Supportive Care

Conditions

Dermatologic Complications

Intervention

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

Location

Hematology Oncology Medical Group of Orange County, Incorporated
Orange
California
United States
92868

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

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

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