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Arm EGF ointment 1ppm will be treated with EGF ointment of 1 ppm concentration

Arm EGF ointment 20ppm will be treated with EGF ointment of 20 ppm concentration

EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day

Arm EGF ointment 1ppm

EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day

Arm EGF ointment 20 ppm

EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day

Arm Placebos

SUNG YONG OH, M.D.

The efficacy of the epidermal growth factor receptor (EGFR) inhibitors have been demonstrated in patients with non-small cell lung cancer (NSCLC), pancreatic cancer (PC) and colorectal cancer (CRC). Dermatological reactions can cause significant physical and psycho-social discomfort to patients. In the present study, the investigators evaluated the effect of epidermal growth factor (EGF) ointment on EGFR inhibitor-related skin side effects (ERSEs).

The current study includes patients diagnosed with advanced NSCLC or PC or CRC, with pathological confirmation. The inclusion criteria were NSCLC treated with erlotinib alone and PC treated with gemcitabine and erlotinib combination chemotherapy and CRC treated with cetuximab and5-Fluorouracil (5-FU)+Irinotecan+leucovorin(LV) (FOLFIRI), 5-FU+Oxaliplatin+LV (FOLFOX) and sufficient liver, kidney, and bone marrow function to undergo treatment. All the patients had Grade ≥2 ERSEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v. 4.03.

The patients will be randomized 3 groups; Placebo group, Arm 1, and Arm 2. Arm 1 will be treated with 1ppm concentration EGF ointment. Arm 2 will be treated with 20ppm concentration EGF ointment. And placebo group will be treated with 0ppm concentration EGF ointment.

Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects

Pilot Trial of Epidermal Growth Factor (EGF) Ointment for the Patients With Epidermal Growth Factor Receptor (EGFR) Inhibitor Related Skin Side Effects

The effectiveness of the EGF ointment was defined as follows:

1. Grade 2, 3, or 4 ERSEs downgraded to ≤Grade 1 or
2. Grade 3 or 4 ERSEs downgraded to Grade 2 and persisting for at least two weeks.

To evaluate the patients' Quality of Life (QoL) by Skin evaluation method (SKINDEX-16)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects	NCT02284139	Non-small Cell ... Pancreatic Canc... Colorectal Canc...	Arm EGF ointmen... Arm EGF ointmen... Arm Placebos	20 Years -	Dong-A University Hospital
Pilot Trial of EGF Ointment for the Patients With EGFR-i Related Skin Side Effects	NCT02284139	Non-small Cell ... Pancreatic Canc... Colorectal Canc...	Arm EGF ointmen... Arm EGF ointmen... Arm Placebos	20 Years -	Dong-A University Hospital

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