Safety and Efficacy of Botulinum Toxin Type A Topical Gel... | NCT02580370

Studies
Safety and Efficacy of Botulinum Toxin Type A Topical Gel for Lateral Canthal Lines

NCT02580370

Sponsor

Revance Therapeutics, Inc.

Status

Completed

Last Update Posted

Sep 9, 2016Estimated

Enrollment

450Actual

Phase

Phase 3

Conditions

Skin Aging

Interventions

Botulinum toxin type A
Placebo comparator

Countries

United States

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

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

Sep 2015

Primary Completion Date

Jul 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Oct 15, 2015

First Submission Date that Met QC Criteria

Oct 19, 2015

First Posted Date

Oct 20, 2015Estimated

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

Sep 7, 2016

Certification/Extension First Submitted that Passed QC Review

Sep 7, 2016

Certification/Extension First Posted Date

Sep 9, 2016Estimated

Last Update Submitted Date

Sep 7, 2016

Last Update Posted Date

Sep 9, 2016Estimated

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

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

450Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose A	Experimental	Botulinum toxin type A	Biological: Botulinum toxin type A
Dose B	Placebo Comparator	Placebo comparator	Biological: Placebo comparator

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Botulinum toxin type A	Biological	Topical botulinum toxin type A	Dose A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite endpoint based upon the investigator global assessment (IGA-LCL) and patient assessment of severity (PSA) of lateral canthal lines		Week 4

Secondary Outcomes

Measure	Description	Time Frame
Investigator Global Assessment with 2 points or greater improvement from baseline	Proportion of subjects with 2 points or greater improvement from baseline using the Investigator Global Assessment	Week 4
Investigator Global Assessment with 1 point or greater improvement from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

In good general health
Moderate to severe lateral canthal lines when evaluated at rest based on the investigator's global assessment
Moderate to severe lateral canthal lines when evaluated at rest based on the patient assessment of severity

Exclusion Criteria:

Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
Muscle weakness or paralysis, particularly in the area receiving study treatment
Active skin disease or irritation or disrupted barrier at the treatment area
Active eye disease or irritation
Eyelid ptosis, excessive dermatochalasis, deep dermal scarring, or inability to substantially effect the LCL to be treated by manually spreading the skin apart
Use of topical prescription retinoid product(s) in the lateral canthal areas during the 3 months prior to Screening
Undergone any procedures that may affect the lateral canthal region during the 12 months prior to Screening
Treatment with botulinum toxin type A in the lateral canthal areas in the 6 months prior to Screening or 3 months anywhere else in the body

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

Facility	Status	City	State	ZIP	Country	Contacts
		Coral Gables	Florida	33146	United States

Intervention Browse Module

MeSH Terms

ID	Term
D019274	Botulinum Toxins, Type A

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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