Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03051880
Status:
UNKNOWN
Last Update Posted:
2017-02-14
First Post:
2016-12-02
Brief Title:
Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
Sponsor:
The Catholic University of Korea
Organization:
The Catholic University of Korea
Study Overview
Official Title:
The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
Status:
UNKNOWN
Status Verified Date:
2017-02
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:
The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors
Detailed Description:
Epidermal growth factor receptorEGFR is involved in cell proliferation and is overexpressed or abnormally activated in malignant tumors originating from the colon breast ovary pancreas and lung EGFR tyrosine kinase inhibitorTKI gefitinib erlotinib and afatinib have been for the treatment of cancer associated with EGFR gene mutation In addition monoclonal antibodies to EGFR such as cetuximab and panitumumab have been used as a chemotherapy for rectal cancer without ras gene mutation and advanced head and neck cancer
The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80 Clinical features include acneform folliculitis xerosis paronychia and itching Of these about 10 of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment resulting in impaired therapeutic results
There have been many attempts to prevent or treat such skin toxicity However there has been no scientifically proven treatment until now
There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors as a result of studies that improve acne significantly compared to placebo
The purpose of this study is to evaluate the preventive efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor TKI or monoclonal antibody
The incidence of cutaneous toxicity of EGFR inhibitors is reported to be 75-80 Clinical features include acneform folliculitis xerosis paronychia and itching Of these about 10 of patients with Grade 3 or greater have a detrimental effect on quality of life and adherence to treatment resulting in impaired therapeutic results
There have been many attempts to prevent or treat such skin toxicity However there has been no scientifically proven treatment until now
There is a growing interest in the role of EGF emulsifiers in the treatment of skin adverse effects of EGFR inhibitors as a result of studies that improve acne significantly compared to placebo
The purpose of this study is to evaluate the preventive efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor TKI or monoclonal antibody
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None