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

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

Tracking Information

• First Submitted Date: December 2, 2016
• First Posted Date: February 9, 2017
• Last Update Posted Date: February 10, 2017
• Study Start Date: November 2016
• Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 7, 2017)

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).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 8, 2017)

• 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.
• 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 ㎍/㎠.
• 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).
• 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).
• The side effects of product [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
  It will be assessed by patient-report.

Original Secondary Outcome Measures (submitted: February 7, 2017)

• The side effects of product [ Time Frame: Baseline, 1 week, 2 weeks, 4 weeks ]
  It will be assessed by patient-report.
• 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.
• 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 /㎍ ㎠.
• 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).
• 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).

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
• Official Title: The Therapeutic Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Drug-Related Side Effects and Adverse Reactions
• Epidermal Growth Factor

Intervention

• 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
• 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

Study Arms

• Experimental: Repair Control EGF®
  EGF cream was applied. Half of face was treated with emollient containing EGF.
  Intervention: Drug: Repair Control EGF®
• 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.
  Intervention: Drug: Cream without rhEGF

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 7, 2017): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03047863
• Other Study ID Numbers: VC16EISI0179
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Jung Min Bae, The Catholic University of Korea
• Study Sponsor: The Catholic University of Korea
• Collaborators: Not Provided

Investigators

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

• PRS Account: The Catholic University of Korea
• Verification Date: February 2017