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

Primary Purpose

Non-small Cell Lung Cancer

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

EVOZAC Calming Skin Spray

Physiological saline

About this trial

This is an interventional prevention trial for Non-small Cell Lung Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EVOZAC

Physiological saline

Arm Description

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

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

Outcomes

Primary Outcome Measures

Lesion counts in total face at completion of the study period (week 4)

Secondary Outcome Measures

Full Information

NCT ID

NCT01528488

First Posted

February 3, 2012

Last Updated

November 4, 2013

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01528488

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

December 2011 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

118 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EVOZAC

Arm Type

Experimental

Arm Description

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

Arm Title

Physiological saline

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

EVOZAC Calming Skin Spray

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Physiological saline

Intervention Description

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 Measure Information:

Title

Lesion counts in total face at completion of the study period (week 4)

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

li zhang, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

12. IPD Sharing Statement

Learn more about this trial

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

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