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

NCT ID: NCT03051880

Last Updated: 2017-02-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2018-12-31

Brief 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

Study Design

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

Study Groups

Repair Control EGF®

EGF cream was applied. One half side of face and one hand were 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 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)

Cream without rhEGF

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.

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 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

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 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)

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 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

Intervention Type: DRUG

Other Intervention Names

EGF cream containing 10 ppm of rhEGF

Eligibility Criteria

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

• 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 B, 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

VC16EISE0180

Identifier Type: -

Identifier Source: org_study_id