NCT03051880

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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 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).

Conditions

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

Interventions

Type	Name	Description
DRUG	Repair Control EGF®	A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 8 weeks. Also, to evaluate the preventive effect of paronychia, patients applied same cream on the finger tips of one side hand, twice a day for 8 weeks. EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)
DRUG	Cream without rhEGF	A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 8 weeks. Patients applied same cream on the finger tips of the other side hand, twice a day for 8 weeks. Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-12-01
• Completion: 2018-12-01
• First posted: 2017-02-14
• Last updated: 2017-02-14

Locations

1 site across 1 country: South Korea