Drug-Related Side Effects and Adverse Reactions Clinical Trial
Official title:
The Preventive Effect of Topical EGF Cream for Dermatologic Adverse Events Related to EGFR Inhibitors
The purpose of this study is to evaluate the preventive efficacy of topical EGF cream for dermatologic adverse events related to EGFR inhibitors.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 2018 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | St. Vincent's Hospital | Suwon | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
The Catholic University of Korea |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The change of acneiform eruption caused by use of EGFR inhibitor | To evaluate the development and severity of acneiform eruption, the investigators take a photograph of full face and hands on every visit. If the acneiform eruption develop, the severity will be assessed based on the Korean Acne Grading System(KAGS). |
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks | |
Secondary | the change paronychia caused by use of EGFR inhibitor | The paronychia lesion will be assessed by CTCAE. | Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks | |
Secondary | the change of skin hydration | It measured with Corneometer® (CM820/825, C-K Electronics, Cologne, Germany). It shows in arbitrary units(AU) and the unit is from 0 to 220. | Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks | |
Secondary | the change of sebum production | It measured with Sebumeter® (SM815; C-K Electronics, Cologne, Germany). It is measured at forehead, cheek and chin, presented as /? ?. It shows in arbitrary units(AU) and the unit is from 0 to 220. | Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks | |
Secondary | Investigator's global assessment score | Investigator's global assessment (IGA) Score will be assessed with 5-point scale (-1 = worsen to 3 =marked improvement). | Baseline, 8 weeks | |
Secondary | Patient's global assessment score | Patient's global assessment (PGA) score will be assessed with a 5-point scale (-1 = worsen, to 3 = marked improvement). | Baseline, 8 weeks | |
Secondary | The side effects of product | It will be assessed by patient-report. - Any event developed during the trials can be reported. |
Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
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