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

Drug-Related Side Effects and Adverse Reactions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03047863
• Other study ID #: VC16EISI0179
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2016
• Last updated: February 8, 2017
• Start date: November 2016
• Est. completion date: December 2017

Study information

• Verified date: February 2017
• Source: The Catholic University of Korea
• Contact: Jung Min Bae, MD, PhD
• Phone: 82-31-249-8209
• Email: jminbae[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 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
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

Locations

Country	Name	City	State
Korea, Republic of	St. Vincent's Hospital	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of severity of acneform eruption induced by EGFR inhibitors	To evaluate the severity of acneiform eruption, the investigators take a photograph of full face. The number of inflammatory and noninflammatory lesions will be counted and accessed the severity based on the Korean Acne Grading System(KAGS).	Baseline, 1 week, 2 weeks, 4 weeks
Secondary	change of skin hydration	Skin hydration is measured with Corneometer® (CM820/825; C-K Electronics, Cologne, Germany).; It shows the skin moisturizing condition in arbitrary units(AU) and the unit is from 0 to 220.	Baseline, 1 week, 2 weeks, 4 weeks
Secondary	change of sebum production	Sebum production is measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany).; It measured at forehead, cheek and chin, presented as ?/?.	Baseline, 1 week, 2 weeks, 4 weeks
Secondary	Investigator's global assessment score	Investigator's global assessment (IGA) Score : It will be assessed as a 5-point scale (-1 = worsen, to 3 = marked improvement).	Baseline, 1 week, 2 weeks, 4 weeks
Secondary	Patient's global assessment score	Patient's global assessment (PGA) score will be assessed as a 5-point scale (-1 = worsen, to 3 =marked improvement).	Baseline, 1 week, 2 weeks, 4 weeks
Secondary	The side effects of product	It will be assessed by patient-report.	Baseline, 1 week, 2 weeks, 4 weeks