Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

Drug-Related Side Effects and Adverse Reactions Clinical Trial

Official title: The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors

Status Recruiting

Clinical Trial Summary

The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.

Clinical Trial Description

Epidermal growth factor receptor(EGFR) 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 inhibitor(TKI), 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). ;

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Epidermal Growth Factor

• NCT number: NCT03051880
• Study type: Interventional
• Source: The Catholic University of Korea
• Contact: Jung Min Bae, MD, PhD
• Phone: 82-31-249-8209
• Email: jminbae@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Completion date: December 2018