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Dose Finding Study In Subjects With Crow's Feet

A

Anterios

Status and phase

Completed
Phase 2

Conditions

Lateral Canthal Lines
Crow's Feet

Treatments

Biological: ANT-1401
Biological: Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT01951742
ANT-1401-LCL-204

Details and patient eligibility

About

The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.

Enrollment

145 patients

Sex

All

Ages

30 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

145 participants in 6 patient groups, including a placebo group

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

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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