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

The Catholic University of Korea

Status: Unknown

Conditions: Drug-Related Side Effects and Adverse Reactions; Epidermal Growth Factor

Treatments: Drug: Cream without rhEGF; Drug: Repair Control EGF®

Study type: Interventional

Funder types: Other

Identifiers

NCT03047863

VC16EISI0179

Details and patient eligibility

About

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

Full 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 therapeutic efficacy of EGF cream in the treatment of skin adverse effects in patients with malignant tumors treated with EGFR inhibitor (TKI or monoclonal antibody).

Enrollment: 20 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who received EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) for malignant tumors
• Patients with EGFR inhibitor-associated skin reactions: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE V4.03) Grade 2, 3 Patients
• Patients who can understand and follow the protocol
• Patients who spontaneously agreed to the study

Exclusion criteria

• NCI-CTCAE grade 4 patients requiring systemic drug therapy
• Those with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks for reasons other than EGFR inhibitors
• Patients with existing acne history
• Patients who have already received anti-EGFR therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Repair Control EGF®

Experimental group

Description:

EGF cream was applied. Half of face was treated with emollient containing EGF.

Treatment:

Drug: Repair Control EGF®

Cream without rhEGF

Placebo Comparator group

Description:

Placebo cream without EGF was applied. The other half of face was treated with only emollient which was not containing EGF.

Treatment:

Drug: Cream without rhEGF