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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01528488
• Other study ID #: EVOZAC20110210
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 3, 2012
• Last updated: November 4, 2013
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

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

Locations

Country	Name	City	State
China	Department of Medical Oncology,Cancer Center of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion counts in total face at completion of the study period (week 4)		12 months	No