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

NCT ID: NCT03047863

Last Updated: 2017-02-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-12-31

Brief Summary

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Repair Control EGF®

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

Group Type: EXPERIMENTAL

Repair Control EGF®

Intervention Type: DRUG

A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 4 weeks.

EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)

Cream without rhEGF

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

Group Type: PLACEBO_COMPARATOR

Cream without rhEGF

Intervention Type: DRUG

A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 4 weeks.

Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF

Interventions

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 4 weeks.

EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)

Intervention Type: 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 4 weeks.

Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF

Intervention Type: DRUG

Other Intervention Names

EGF cream containing 10 ppm of rhEGF

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Jung Min Bae

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jung Min Bae, MD, PhD

Role: STUDY_CHAIR

The Catholic University of Korea

Locations

St. Vincent's Hospital

Suwon, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Jung Min Bae, MD, PhD

Role: CONTACT

jminbae@gmail.com

82-31-249-8209

Ho jung An, MD, PhD

Role: CONTACT

strhojung@gmail.com

82-10-8737-4285

Facility Contacts

Jung Min Bae, MD

Role: primary

jminbae@gmail.com

82-31-249-8209

Other Identifiers

VC16EISI0179

Identifier Type: -

Identifier Source: org_study_id