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Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors

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ClinicalTrials.gov Identifier: NCT03047863
Recruitment Status : Unknown
Verified February 2017 by Jung Min Bae, The Catholic University of Korea.
Recruitment status was:  Recruiting
First Posted : February 9, 2017
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Jung Min Bae, The Catholic University of Korea

Study Description
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Brief Summary:
The purpose of this study is to evaluate the therapeutic efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.

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

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 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Therapeutic Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
Study Start Date : November 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Repair Control EGF®
EGF cream was applied. Half of face was 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 4 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 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 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


Outcome Measures
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Primary Outcome Measures :
  1. The change of severity of acneform eruption induced by EGFR inhibitors [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    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).


Secondary Outcome Measures :
  1. change of skin hydration [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]

    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.


  2. change of sebum production [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]

    Sebum production is measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany).

    It measured at forehead, cheek and chin, presented as ㎍/㎠.


  3. Investigator's global assessment score [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    Investigator's global assessment (IGA) Score : It will be assessed as a 5-point scale (-1 = worsen, to 3 = marked improvement).

  4. Patient's global assessment score [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    Patient's global assessment (PGA) score will be assessed as a 5-point scale (-1 = worsen, to 3 =marked improvement).

  5. The side effects of product [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
    It will be assessed by patient-report.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received EGFR inhibitors (gefitinib, erlotinib, afatinib, cetuximab, etc.) for malignant tumors
  • Patients with EGFR inhibitor-associated skin reactions: National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE V4.03) Grade 2, 3 Patients
  • Patients who can understand and follow the protocol
  • Patients who spontaneously agreed to the study

Exclusion Criteria:

  • NCI-CTCAE grade 4 patients requiring systemic drug therapy
  • Those with a history of antibiotic treatment, local and systemic steroid therapy within 4 weeks for reasons other than EGFR inhibitors
  • Patients with existing acne history
  • Patients who have already received anti-EGFR therapy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047863


Contacts
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Contact: Jung Min Bae, MD, PhD 82-31-249-8209 jminbae@gmail.com
Contact: Ho jung An, MD, PhD 82-10-8737-4285 strhojung@gmail.com

Locations
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Korea, Republic of
St. Vincent's Hospital Recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 16247
Contact: Jung Min Bae, MD    82-31-249-8209    jminbae@gmail.com   
Sponsors and Collaborators
The Catholic University of Korea
Investigators
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Study Chair: Jung Min Bae, MD, PhD The Catholic University of Korea
More Information
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Responsible Party: Jung Min Bae, Clinical Assistant Professor, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT03047863    
Other Study ID Numbers: VC16EISI0179
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jung Min Bae, The Catholic University of Korea:
Epidermal Growth Factor
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders