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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01528488
Recruitment Status : Completed
First Posted : February 8, 2012
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Other: EVOZAC Calming Skin Spray Other: Physiological saline Phase 2 Phase 3

Detailed Description:
Not suitable: no more information is needed to be described.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Prospective Trial of Prophylactic EVOZAC® Calming Skin Spray for EGFR-TKIs Associated Rash Eruption in Non-small Cell Lung Cancer
Study Start Date : December 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: EVOZAC
EVOZAC should be sprayed to the skin of the total face three times per day.
Other: EVOZAC Calming Skin Spray
EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day

Placebo Comparator: Physiological saline
Physiological saline should be sprayed to 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

Primary Outcome Measures :
  1. Lesion counts in total face at completion of the study period (week 4) [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven NSCLC diagnosis
  • Life expectancy over four weeks
  • absolute neutrophil count ≥ 2.0X109/L, Pt ≥ 100X109/L, hemoglobin ≥ 90g/l
  • With normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and Total bilirubin ≤ upper limit of normal)
  • Suitable for EGFR-TKIs treatment and expectant duration over four weeks
  • No specific therapies received within 4 weeks prior to enrollment which may induce similar skin reaction,such as Cetuximab, Sorafenib, Avastin.
  • With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI-CTC] grade ≥ 3)
  • No other concomitant therapy referred to the face skin during the study
  • Signed and dated informed consent

Exclusion Criteria:

  • Performance status ≥ 3(ECOG)
  • Pregnant or breast-feeding patients
  • The lesion counts can't be evaluated due to concomitant diseases or other conditions
  • Not suitable for EGFR-TKIs treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01528488

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China, Guangdong
Department of Medical Oncology,Cancer Center of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
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Principal Investigator: li zhang, MD Sun Yat-sen University

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Responsible Party: Li Zhang, professor, Sun Yat-sen University Identifier: NCT01528488     History of Changes
Other Study ID Numbers: EVOZAC20110210
First Posted: February 8, 2012    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms