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Clinical Trial Summary

RATIONALE: Regenecare® wound gel may help relieve pain and itching in patients who develop an acne-like rash while undergoing treatment with cetuximab or another epidermal growth factor receptor inhibitor for cancer.

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


Clinical Trial Description

OBJECTIVES:

Primary

- Determine the efficacy of Regenecare® wound gel in alleviating pain and itching in patients who develop an acneiform rash while undergoing treatment with cetuximab or other EGFR inhibitor therapy for cancer.

Secondary

- Determine the efficacy of this drug in reducing the severity of rash in these patients.

- Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.

- Determine the tolerability of this drug in these patients.

OUTLINE: This is a prospective study.

- Observation: Patients undergo evaluation by full-face photography prior to development of skin rash (baseline). While undergoing concurrent cancer therapy, patients self-monitor for the appearance of an acneiform rash. Upon initial onset of rash, patients proceed to treatment.

- Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.

Patients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires. ;


Study Design

Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT00498992
Study type Interventional
Source National Cancer Institute (NCI)
Contact
Status Recruiting
Phase N/A
Start date July 2006

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