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

Phase 2

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Other: EVOZAC Calming Skin Spray; Other: Physiological saline

• Registration Number: NCT01528488
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-03
• Study First Submitted QC: 2012-02-07
• Study First Posted: 2012-02-08
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-04
• Last Update Posted: 2013-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EVOZAC	EVOZAC Calming Skin Spray	EVOZAC should be sprayed to the skin of the total face three times per day.
Physiological saline	Physiological saline	Physiological saline should be sprayed to the total face three times per day.

Primary Outcome Measures

Name	Time	Method
Lesion counts in total face at completion of the study period (week 4)	12 months

Trial Locations

Locations (1)

Department of Medical Oncology,Cancer Center of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China