NCT01809964

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 10, 2014

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

March 7, 2013

Last Update Submit

December 10, 2013

Conditions

Lateral Canthal LinesCrows Feet

Outcome Measures

Primary Outcomes (1)

  • Investigator's Global Assessment Scale

    Week 4

Secondary Outcomes (1)

  • Subject Self-Assessment

    Week 4

Study Arms (3)

Dose 1

EXPERIMENTAL

ANT-1401

Biological: ANT-1401

Dose 2

EXPERIMENTAL

ANT-1401

Biological: ANT-1401

Vehicle

PLACEBO COMPARATOR

Placebo Vehicle

Biological: Vehicle

Interventions

ANT-1401BIOLOGICAL
Dose 1Dose 2
VehicleBIOLOGICAL
Vehicle

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Unknown Facility

Birmingham, Alabama, 35205, United States

Location

Unknown Facility

Miami, Florida, 33137, United States

Location

Unknown Facility

Pinellas Park, Florida, 33781, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Metairie, Louisiana, 70006, United States

Location

Unknown Facility

Knoxville, Tennessee, 37922, United States

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

January 10, 2014

Record last verified: 2013-12

Locations

US(7)