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

Anterios

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines; Crows Feet

Treatments: Biological: Vehicle; Biological: ANT-1401

Study type: Interventional

Funder types: Industry

Identifiers

NCT01809964

ANT-1401-LCL-203

Details and patient eligibility

About

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

Enrollment: 109 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 (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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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109 participants in 3 patient groups, including a placebo group

Dose 1

Experimental group

Description:

ANT-1401

Treatment:

Biological: ANT-1401

Dose 2

Experimental group

Description:

ANT-1401

Treatment:

Biological: ANT-1401

Vehicle

Placebo Comparator group

Description:

Placebo Vehicle

Treatment:

Biological: Vehicle