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The epidermal growth factor receptor (EGFR) has become an important target for cancer therapy, and the small molecular tyrosine kinase inhibitors (EGFR-TKIs) have played an important role in the treatment of non-small cell lung cancer (NSCLC). What accompanies with the encouraging efficacy in NSCLC is the common side effects, of which the most common one is the specific papular and pustular acne-like rash which affects mainly the face, scalp, and upper torso. But till now, no medicament has been proved effective enough to treat or prevent the EGFR-TKIs associated rash. The EVOZACĀ® Calming Skin Spray has shown acceptable activity at the rash prevention in our preliminary study, so the investigators conduct the randomized, double-blind, controlled trial to evaluate the efficacy and safety of EVOZACĀ® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVOZAC | Experimental | EVOZAC should be sprayed to the skin of the total face three times per day. |
|
| Physiological saline | Placebo Comparator | Physiological saline should be sprayed to the total face three times per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVOZAC Calming Skin Spray | Other | EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lesion counts in total face at completion of the study period (week 4) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| li zhang, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology,Cancer Center of Sun Yat-Sen University | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Physiological saline | Other | Physiological saline was used as the placebo of EVOZACĀ® Calming Skin Spray and should be also sprayed on the total face, three times per day |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |