Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
|ClinicalTrials.gov Identifier: NCT00498992|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : July 11, 2007
Last Update Posted : September 20, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Dermatologic Complications Unspecified Adult Solid Tumor, Protocol Specific||Dietary Supplement: collagen/aloe vera/vitamin E/lidocaine topical hydrogel||Not Applicable|
- 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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients|
|Study Start Date :||July 2006|
- Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching
- Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash
- Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00498992
|United States, Illinois|
|Ingalls Cancer Care Center at Ingalls Memorial Hospital||Recruiting|
|Harvey, Illinois, United States, 60426|
|Contact: Clinical Trials Office - Ingalls Cancer Care Center at Ingalls 708-915-4673|
|Study Chair:||Mark F. Kozloff, MD||Ingalls Memorial Hospital|