Dose Finding Study In Subjects With Crow's Feet

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

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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