Clinical Trial to Evaluate ANT-1401 in Crow's Feet | NCT01809964

Studies
Clinical Trial to Evaluate ANT-1401 in Crow's Feet

NCT01809964

Sponsor

Anterios Inc.

Status

Completed

Last Update Posted

Jan 10, 2014Estimated

Enrollment

109Actual

Phase

Phase 2

Conditions

Lateral Canthal Lines
Crows Feet

Interventions

ANT-1401
Vehicle

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

Dec 2013

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

Mar 2013

Primary Completion Date

Jun 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Mar 7, 2013

First Submission Date that Met QC Criteria

Mar 11, 2013

First Posted Date

Mar 13, 2013Estimated

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

Nov 15, 2013

Certification/Extension First Submitted that Passed QC Review

Nov 15, 2013

Certification/Extension First Posted Date

Dec 10, 2013Estimated

Last Update Submitted Date

Dec 10, 2013

Last Update Posted Date

Jan 10, 2014Estimated

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

The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

109Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose 1	Experimental	ANT-1401	Biological: ANT-1401
Dose 2	Experimental	ANT-1401	Biological: ANT-1401
Vehicle	Placebo Comparator	Placebo Vehicle	Biological: Vehicle

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANT-1401	Biological		Dose 1 Dose 2
Vehicle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigator's Global Assessment Scale		Week 4

Secondary Outcomes

Measure	Description	Time Frame
Subject Self-Assessment		Week 4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

30 - 60 years of age
mild to moderate Crow's Feet wrinkles (IGA 1-2) at rest
moderate to severe Crow's Feet (IGA 2-3) on contraction
moderate to severe Crow's Feet (SSA 2-3) on contraction
Have adequate vision to assess facial wrinkles in a mirror

Exclusion Criteria:

botulinum toxin treatment in the prior 6 months
history of periocular surgery, brow lift or related procedures
soft tissue augmentation in the lateral canthal region in the prior 12 months
dermabrasion or laser treatment in the periocular region in the last 6 months
topical prescription-strength retinoids in the prior 3 months
present or history of neuromuscular disease
present or history of "dry eye"
systemic aminoglycoside use in the week prior to treatment application

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35205	United States