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EGF Ointment for Erlotinib Skin Lesion

NCT01593995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2014-11-04

No results posted yet for this study

Summary

Epidermal growth factor receptor-tyrosin kinase inhibitor (EGFR-TKI, Erlotinib) has demonstrated its efficacy in patients with non-small cell lung cancer and pancreatic cancer. But, their use is associated with dermatologic reactions of varying severity. Incidence of Erlotinib related skin effect (ERSE) was reported \~75% in NSCLC and pancreatic cancer phase III trials. Even though the dermatologic reactions could be a surrogated marker, it may be cause of dose modification. Also, it could give significant physical and psycho-social discomfort to patients. However, there is still a wide variety of drugs used- including, steroid, antibiotics, and vitamin D without any clear evidence based management recommendation.

The role of epidermal growth factor (EGF) has been extensively investigated in normal and pathological wound healing. It is implicated in keratinocyte migration, fibroblast function and the formation of granulation tissue. The first growth factor to be isolated growth factor therapy has progressed into clinical practice in the treatment of wounds.

Therefore, the investigators propose an epidermal growth factor ointment apply for patients with Erlotinib related skin effects.

Conditions

  • Non-small Cell Lung Cancer
  • Pancreatic Cancer

Interventions

DRUG

Epidermal growth factor (EGF) ointment

EGF Ointment evenly apply to skin lesion every 12 hr/ day. If the skin lesion has been no improvement even though EGF ointment applied for 8 weeks, stopped study and assess it as "no effect"

Sponsors & Collaborators

  • Dong-A University Hospital

    lead OTHER

Principal Investigators

  • Sung Yong Oh, M.D.,Ph.D. · Onclogy Division, Dong-A University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-12-31
Completion
2014-10-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01593995 on ClinicalTrials.gov