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

• ClinicalTrials.gov Identifier: NCT03051880
• Recruitment Status: Unknown
• First Posted: February 14, 2017
• Last Update Posted: February 14, 2017
• Sponsor: The Catholic University of Korea
• Information provided by (Responsible Party): Jung Min Bae, The Catholic University of Korea

Study Description

Brief Summary:

The purpose of this study is to evaluate the preventive 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 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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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

Arms and Interventions

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.	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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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).
5. 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).
6. 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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Contacts

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

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

• Study Chair: Jung Min B, MD, PhD; The Catholic University of Korea

More Information

• Responsible Party: Jung Min Bae, Clinical Assistant Professor, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT03051880
• Other Study ID Numbers: VC16EISE0180
• First Posted: February 14, 2017
• Last Update Posted: February 14, 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:

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders