Preventive 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: NCT03051880
• Lead Sponsor: The Catholic University of Korea

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).

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-02
• Status Verified: 2017-02
• Study First Submitted QC: 2017-02-09
• Last Update Submitted: 2017-02-09
• Study First Posted: 2017-02-14
• Last Update Posted: 2017-02-14
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Repair Control EGF®	Repair Control EGF®	EGF cream was applied. One half side of face and one hand were treated with emollient containing EGF.
Cream without rhEGF	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.

Primary Outcome Measures

Name	Time	Method
The change of acneiform eruption caused by use of EGFR inhibitor	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
the change of skin hydration	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks	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.
the change of sebum production	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks	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.
The side effects of product	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks	It will be assessed by patient-report.; - Any event developed during the trials can be reported.
Investigator's global assessment score	Baseline, 8 weeks	Investigator's global assessment (IGA) Score will be assessed with 5-point scale (-1 = worsen to 3 =marked improvement).
the change paronychia caused by use of EGFR inhibitor	Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks	The paronychia lesion will be assessed by CTCAE.
Patient's global assessment score	Baseline, 8 weeks	Patient's global assessment (PGA) score will be assessed with a 5-point scale (-1 = worsen, to 3 = marked improvement).

Trial Locations

Locations (1)

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