An interventional study of Repair Control EGF® and Cream without rhEGF in Drug-Related Side Effects and Adverse Reactions and Epidermal Growth Factor, sponsored by The Catholic University of Korea. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by The Catholic University of Korea · Not applicable, Interventional, and Treatment
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).
437 studies on the registry are indexed under Drug-Related Side Effects and Adverse Reactions; 76 are open to participants now.
This study's planned enrollment of 20 is below the median of 103 across 255 interventional studies indexed under Drug-Related Side Effects and Adverse Reactions.
Browse Drug-Related Side Effects and Adverse Reactions studies →The Catholic University of Korea is the lead sponsor of 150 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
EGF cream was applied. Half of face was treated with emollient containing EGF.
Drug: Repair Control EGF®
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 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)
Also known as: EGF cream containing 10 ppm of 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
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).
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
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.
Time frame: 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 ㎍/㎠.
Time frame: 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).
Time frame: 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).
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
The side effects of product
It will be assessed by patient-report.
Time frame: Baseline, 1 week, 2 weeks, 4 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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The Catholic University of Korea