Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00498992
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2007-07-10
Brief Title:
Regenecare Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
Sponsor:
Ingalls Memorial Hospital
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Regenecare in the Treatment of Skin Rash Associated With Cetuximab Erbitux or Other EGFR Treated Cancer Patients
Status:
UNKNOWN
Status Verified Date:
2009-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MPMM-IMH-REG-ING-100 | None | None | None |
| IMH-REG-ING-100 | None | None | None |