Clinical trial NCT03047863: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drug-Related Side Effects and Adverse Reactions
Epidermal Growth Factor
Keywords: Epidermal Growth Factor
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2017-02-09
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The change of severity of acneform eruption induced by EGFR inhibitors
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
Secondary outcomes:
measure: change of skin hydration
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: change of sebum production
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: Investigator's global assessment score
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: Patient's global assessment score
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
measure: The side effects of product
timeFrame: Baseline, 1 week, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
state: Gyeonggi-do
Study officials:
affiliation: The Catholic University of Korea
name: Jung Min Bae, MD, PhD
role: STUDY_CHAIR
References: