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

Drug-Related Side Effects and Adverse Reactions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03051880
• Other study ID #: VC16EISE0180
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2016
• Last updated: February 9, 2017
• Start date: November 2016
• Est. completion date: December 2018

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 preventive 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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

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 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
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

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 acneiform eruption caused by use of EGFR inhibitor	To evaluate the development and severity of acneiform eruption, the investigators take a photograph of full face and hands on every visit.; If the acneiform eruption develop, the severity will be assessed based on the Korean Acne Grading System(KAGS).	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary	the change paronychia caused by use of EGFR inhibitor	The paronychia lesion will be assessed by CTCAE.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary	the change of skin hydration	It measured with Corneometer® (CM820/825, C-K Electronics, Cologne, Germany). It shows in arbitrary units(AU) and the unit is from 0 to 220.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary	the change of sebum production	It measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany). It is measured at forehead, cheek and chin, presented as /? ?. It shows in arbitrary units(AU) and the unit is from 0 to 220.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary	Investigator's global assessment score	Investigator's global assessment (IGA) Score will be assessed with 5-point scale (-1 = worsen to 3 =marked improvement).	Baseline, 8 weeks
Secondary	Patient's global assessment score	Patient's global assessment (PGA) score will be assessed with a 5-point scale (-1 = worsen, to 3 = marked improvement).	Baseline, 8 weeks
Secondary	The side effects of product	It will be assessed by patient-report.; - Any event developed during the trials can be reported.	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks