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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

Tracking Information
First Submitted Date  ICMJE December 2, 2016
First Posted Date  ICMJE February 9, 2017
Last Update Posted Date February 10, 2017
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Therapeutic Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Drug-Related Side Effects and Adverse Reactions
  • Epidermal Growth Factor
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 7, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03047863
Other Study ID Numbers  ICMJE VC16EISI0179
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jung Min Bae, The Catholic University of Korea
Study Sponsor  ICMJE The Catholic University of Korea
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jung Min Bae, MD, PhD The Catholic University of Korea
PRS Account The Catholic University of Korea
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP