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

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

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

Study Overview

• Status: Unknown
• Conditions: Drug-Related Side Effects and Adverse Reactions; Epidermal Growth Factor
• Intervention / Treatment: Drug: Repair Control EGF®; Drug: Cream without rhEGF

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).

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon, Gyeonggi-do, Korea, Republic of, 16247
      • Recruiting
      • St. Vincent's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repair Control EGF®; EGF cream was applied. Half of face was treated with emollient containing EGF.	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); Other Names: EGF cream containing 10 ppm of rhEGF
Placebo Comparator: Cream without rhEGF; Placebo cream without EGF was applied. The other half of face was treated with only emollient which was not containing EGF.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
The side effects of product	It will be assessed by patient-report.	Baseline, 1 week, 2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: The Catholic University of Korea
• Investigators: Study Chair: Jung Min Bae, MD, PhD, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): August 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): February 10, 2017
• Last Update Submitted That Met QC Criteria: February 8, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Epidermal Growth Factor
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Drug-Related Side Effects and Adverse Reactions
• Other Study ID Numbers: VC16EISI0179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided