Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
|ClinicalTrials.gov Identifier: NCT03051880|
Recruitment Status : Unknown
Verified February 2017 by Jung Min Bae, The Catholic University of Korea.
Recruitment status was: Recruiting
First Posted : February 14, 2017
Last Update Posted : February 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Drug-Related Side Effects and Adverse Reactions Epidermal Growth Factor||Drug: Repair Control EGF® Drug: Cream without rhEGF||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: Repair Control EGF®
EGF cream was applied. One half side of face and one hand were 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 8 weeks. Also, to evaluate the preventive effect of paronychia, patients applied same cream on the finger tips of one side hand, twice a day for 8 weeks.
EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)
Other Name: EGF cream containing 10 ppm of rhEGF
Placebo Comparator: 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.
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 8 weeks. Patients applied same cream on the finger tips of the other side hand, twice a day for 8 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 acneiform eruption caused by use of EGFR inhibitor [ Time Frame: 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).
- the change paronychia caused by use of EGFR inhibitor [ Time Frame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks ]The paronychia lesion will be assessed by CTCAE.
- the change of skin hydration [ Time Frame: 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 [ Time Frame: 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.
- Investigator's global assessment score [ Time Frame: Baseline, 8 weeks ]Investigator's global assessment (IGA) Score will be assessed with 5-point scale (-1 = worsen to 3 =marked improvement).
- Patient's global assessment score [ Time Frame: Baseline, 8 weeks ]Patient's global assessment (PGA) score will be assessed with a 5-point scale (-1 = worsen, to 3 = marked improvement).
- The side effects of product [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051880
|Contact: Jung Min Bae, MD, PhDfirstname.lastname@example.org|
|Contact: Ho jung An, MD, PhDemail@example.com|
|Korea, Republic of|
|St. Vincent's Hospital||Recruiting|
|Suwon, Gyeonggi-do, Korea, Republic of, 16247|
|Contact: Jung Min Bae, MD 82-31-249-8209 firstname.lastname@example.org|
|Study Chair:||Jung Min B, MD, PhD||The Catholic University of Korea|