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The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Repair Control EGF® | Experimental | EGF cream was applied. Half of face was treated with emollient containing EGF. |
|
| Cream without rhEGF | Placebo Comparator | Placebo cream without EGF was applied. The other half of face was treated with only emollient which was not containing EGF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repair Control EGF® | Drug | 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) |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung Min Bae, MD, PhD | Contact | 82-31-249-8209 | jminbae@gmail.com | |
| Ho jung An, MD, PhD | Contact | 82-10-8737-4285 | strhojung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jung Min Bae, MD, PhD | The Catholic University of Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Recruiting | Suwon | Gyeonggi-do | 16247 | South Korea |
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| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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|
| Cream without rhEGF | Drug | 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 |
|
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 |