Clinical trial NCT03051880: Preventive Effect of EGF Cream for Cutaneous Adverse Event of EGFR Inhibitors
Official title: The Preventive 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: 2017-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility 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

Primary outcomes:
measure: The change of acneiform eruption caused by use of EGFR inhibitor
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
Secondary outcomes:
measure: the change paronychia caused by use of EGFR inhibitor
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: the change of skin hydration
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: the change of sebum production
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks
measure: Investigator's global assessment score
timeFrame: Baseline, 8 weeks
measure: Patient's global assessment score
timeFrame: Baseline, 8 weeks
measure: The side effects of product
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 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 B, MD, PhD
role: STUDY_CHAIR
References: