Dose Finding Study In Subjects With Crow's Feet | NCT01951742

Studies
Dose Finding Study In Subjects With Crow's Feet

NCT01951742

Sponsor

Anterios Inc.

Status

Completed

Last Update Posted

May 29, 2014Estimated

Enrollment

145Actual

Phase

Phase 2

Conditions

Lateral Canthal Lines
Crow's 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

May 2014

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 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Jan 2014Actual

First Submitted Date

Sep 22, 2013

First Submission Date that Met QC Criteria

Sep 24, 2013

First Posted Date

Sep 27, 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

May 20, 2014

Certification/Extension First Submitted that Passed QC Review

May 20, 2014

Certification/Extension First Posted Date

May 29, 2014Estimated

Last Update Submitted Date

May 20, 2014

Last Update Posted Date

May 29, 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 establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.

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

145Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vehicle	Placebo Comparator	vehicle without ANT-1401	Biological: Vehicle
Dose 1	Experimental	lowest dose	Biological: ANT-1401
Dose 2	Experimental	second lowest dose	Biological: ANT-1401
Dose 3	Experimental	mid-level dose	Biological: ANT-1401
Dose 4	Experimental	second highest dose	Biological: ANT-1401
Dose 5	Experimental	highest dose	Biological: ANT-1401

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ANT-1401	Biological	Active	Dose 1 Dose 2 Dose 3 Dose 4 Dose 5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigators Global Assessment Scale	Crow's Feet Wrinkle Scale	Week 4

Secondary Outcomes

Measure	Description	Time Frame
Subject Self-Assessment score	Subjects self assessment of severity of Crow's Feet	up to 12 12 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

30 - 60 years of age
mild to moderate Crow's Feet wrinkles at rest
moderate to severe Crow's Feet wrinkles on contraction
willingness to refrain from any product affecting skin remodeling
female subjects must be not pregnant and non-lactating

Exclusion Criteria:

history of peri-ocular surgery, brow lift or related procedures
procedures affecting the lateral canthal region in the prior 12 months
application of topical prescription medication to the treatment area
female subjects who are pregnant or are nursing a child

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
		Miami	Florida	33137	United States