A Study Of BOTOX For The Treatment Of Glabellar Lines | NCT00408785

Studies
A Study Of BOTOX For The Treatment Of Glabellar Lines

NCT00408785

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

May 31, 2017Actual

Enrollment

256

Phase

Phase 3

Conditions

Glabellar Lines

Interventions

Botulinum Toxin Type A
sodium chloride

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2006Actual

Primary Completion Date

May 9, 2007Actual

Completion Date

May 9, 2007Actual

First Submitted Date

Dec 6, 2006

First Submission Date that Met QC Criteria

Dec 6, 2006

First Posted Date

Dec 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2017

Last Update Posted Date

May 31, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

256

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Experimental	Injection	Drug: Botulinum Toxin Type A
B	Placebo Comparator	Injection	Drug: sodium chloride

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum Toxin Type A	Drug	botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The investigator's rating of Glabellar line severity at maximum frown		Day 30 after injection

Secondary Outcomes

Measure	Description	Time Frame
Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.		Day 7, 30, 60, 90, 120 after injection

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment.

Exclusion criteria:

Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible.
Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Beijing		100034	China
GSK Investigational Site

Type	Date	Date Unknown
Release	Jul 11, 2017
Reset	Dec 1, 2017
Release	Dec 7, 2017
Unrelease	Aug 15, 2018

Submission Tracking

Estimated Results First Submitted Date

Jul 11, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jul 11, 2017			Dec 1, 2017
Dec 7, 2017	Aug 15, 2018

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A
D012965	Sodium Chloride

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases

Browse Leaves

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Browse Branches

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