- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03051880
Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gyeonggi-do
-
Suwon, Gyeonggi-do, Korea, Republic of, 16247
- Recruiting
- St. Vincent's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Repair Control EGF®
EGF cream was applied.
One half side of face and one hand were treated with emollient containing 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 Names:
|
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.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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). |
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
|
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.
|
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
|
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.
|
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
|
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).
|
Baseline, 8 weeks
|
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).
|
Baseline, 8 weeks
|
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. |
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jung Min B, MD, PhD, The Catholic University of Korea
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VC16EISE0180
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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