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

NCT ID: NCT01528488

Last Updated: 2013-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-07-31

Brief Summary

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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 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

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

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EVOZAC

EVOZAC should be sprayed to the skin of the total face three times per day.

Group Type EXPERIMENTAL

EVOZAC Calming Skin Spray

Intervention Type OTHER

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

Physiological saline

Physiological saline should be sprayed to the total face three times per day.

Group Type PLACEBO_COMPARATOR

Physiological saline

Intervention Type OTHER

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

Interventions

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EVOZAC Calming Skin Spray

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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Li Zhang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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li zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Department of Medical Oncology,Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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EVOZAC20110210

Identifier Type: -

Identifier Source: org_study_id