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Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in NSCLC

NCT01528488 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2013-11-05

No results posted yet for this study

Summary

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 EVOZAC® 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 EVOZAC® Calming Skin Spray in prevention of EGFR-TKIs associated rash in NSCLC.

Conditions

  • Non-small Cell Lung Cancer

Interventions

OTHER

EVOZAC Calming Skin Spray

EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day

OTHER

Physiological saline

Physiological saline was used as the placebo of EVOZAC® Calming Skin Spray and should be also sprayed on the total face, three times per day

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • li zhang, MD · Sun Yat-sen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-06-30
Completion
2013-07-31

Countries

  • China

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 NCT01528488 on ClinicalTrials.gov