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

Not Applicable

• Conditions: Drug-Related Side Effects and Adverse Reactions; Epidermal Growth Factor
• Interventions: Drug: Repair Control EGF®; Drug: Cream without rhEGF

• Registration Number: NCT03047863
• Lead Sponsor: The Catholic University of Korea

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).

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-02
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-08
• Study First Posted: 2017-02-09
• Last Update Posted: 2017-02-10
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repair Control EGF®	Repair Control EGF®	EGF cream was applied. Half of face was treated with emollient containing EGF.
Cream without rhEGF	Cream without rhEGF	Placebo cream without EGF was applied. The other half of face was treated with only emollient which was not containing EGF.

Primary Outcome Measures

Name	Time	Method
The change of severity of acneform eruption induced by EGFR inhibitors	Baseline, 1 week, 2 weeks, 4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
change of skin hydration	Baseline, 1 week, 2 weeks, 4 weeks	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.
change of sebum production	Baseline, 1 week, 2 weeks, 4 weeks	Sebum production is measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany).; It measured at forehead, cheek and chin, presented as ㎍/㎠.
Investigator's global assessment score	Baseline, 1 week, 2 weeks, 4 weeks	Investigator's global assessment (IGA) Score : It will be assessed as a 5-point scale (-1 = worsen, to 3 = marked improvement).
Patient's global assessment score	Baseline, 1 week, 2 weeks, 4 weeks	Patient's global assessment (PGA) score will be assessed as a 5-point scale (-1 = worsen, to 3 =marked improvement).
The side effects of product	Baseline, 1 week, 2 weeks, 4 weeks	It will be assessed by patient-report.

Trial Locations

Locations (1)

St. Vincent's Hospital; 🇰🇷 Suwon, Gyeonggi-do, Korea, Republic of