Preventive 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

NCT03051880

VC16EISE0180

Details and patient eligibility

About

The purpose of this study is to evaluate the preventive 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 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 20 years old
• Patients scheduled to receive EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) as malignant tumors
• Patients who can understand and follow the protocol
• Patients who spontaneously agreed to the study

Exclusion criteria

• Patients with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks of other skin disorders
• Patients with existing acne history
• Breastfeeding or pregnant women
• Patients who are deemed unsuitable for the examination by the researcher's judgment

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Repair Control EGF®

Experimental group

Description:

EGF cream was applied. One half side of face and one hand were 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 side of face and the other hand were treated with only emollient which was not containing EGF.

Treatment:

Drug: Cream without rhEGF