Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|