Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-03-01 @ 3:22 AM
Study NCT ID:
NCT00498992
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
2007-07-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2013-09-19', 'studyFirstSubmitDate': '2007-07-10', 'studyFirstSubmitQcDate': '2007-07-10', 'lastUpdatePostDateStruct': {'date': '2013-09-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of Regenecare® wound gel, in terms of alleviating pain and itching'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Regenecare® wound gel, in terms of reducing severity, redness, and appearance of rash'}, {'measure': 'Tolerability of Regenecare® wound gel as assessed by NCI CTCAE v3.0'}]}, 'conditionsModule': {'keywords': ['dermatologic complications', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Dermatologic Complications', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: 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.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* 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.\n\nSecondary\n\n* Determine the efficacy of this drug in reducing the severity of rash in these patients.\n* Determine the efficacy of this drug in reducing the redness and appearance of the rash in these patients.\n* Determine the tolerability of this drug in these patients.\n\nOUTLINE: This is a prospective study.\n\n* 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.\n* Treatment: Patients apply topical Regenecare® wound gel to the face ≥ 4 times daily. Treatment continues for 4 weeks in the absence of unacceptable toxicity.\n\nPatients are evaluated weekly by facial examination, full-face photography, and patient satisfaction questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of cancer\n* Starting treatment with cetuximab or other EGFR inhibitor (e.g., erlotinib hydrochloride) on another clinical trial\n\nPATIENT CHARACTERISTICS:\n\n* Not pregnant or nursing\n* No known history of hypersensitivity to amine-type local anesthetics or to other components of MPM Regenecare® wound gel\n* No other concurrent, serious skin disorders (i.e., scleroderma or psoriasis) that would interfere with assessment of EGFR inhibitor-induced rash\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No other concurrent topical facial creams or lotions'}, 'identificationModule': {'nctId': 'NCT00498992', 'briefTitle': 'Regenecare® Wound Gel in Treating Rash in Patients Receiving Cetuximab or Other Epidermal Growth Factor Receptor Inhibitor Therapy for Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'Regenecare® in the Treatment of Skin Rash Associated With Cetuximab (Erbitux®) or Other EGFR Treated Cancer Patients', 'orgStudyIdInfo': {'id': 'CDR0000553120'}, 'secondaryIdInfos': [{'id': 'IMH-REG-ING-100'}, {'id': 'MPMM-IMH-REG-ING-100'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'collagen/aloe vera/vitamin E/lidocaine topical hydrogel', 'type': 'DIETARY_SUPPLEMENT'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Trials Office - Ingalls Cancer Care Center at Ingalls', 'role': 'CONTACT', 'phone': '708-915-4673'}], 'facility': 'Ingalls Cancer Care Center at Ingalls Memorial Hospital', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}], 'overallOfficials': [{'name': 'Mark F. Kozloff, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ingalls Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ingalls Memorial Hospital', 'class': 'OTHER'}}}}