Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet

Anterios

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines; Crow's Feet

Treatments: Biological: ANT-1207; Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01358695

ANT-1207-201-LCL

Details and patient eligibility

About

The purpose of this study is to provide evidence of the safety, tolerance, and efficacy of ANT-1207 in the treatment of Crow's Feet.

Enrollment: 111 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• mild to moderate Crow's Feet wrinkles (IGA 2-3) at rest
• moderate to severe Crow's Feet (IGA 3-4) 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: Factorial Assignment

Masking: Quadruple Blind

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111 participants in 6 patient groups, including a placebo group

Placebo Comparator

Placebo Comparator group

Treatment:

Biological: ANT-1207

Biological: Botulinum Toxin Type A

Dose 1

Experimental group

Description:

Dose 1

Treatment:

Biological: Botulinum Toxin, Type A

Biological: ANT-1207

Biological: Botulinum Toxin Type A

Dose 2

Experimental group

Description:

Dose 2

Treatment:

Biological: Botulinum Toxin, Type A

Biological: ANT-1207

Biological: Botulinum Toxin Type A

Dose 3

Experimental group

Description:

Dose 3

Treatment:

Biological: Botulinum Toxin, Type A

Biological: ANT-1207

Biological: Botulinum Toxin Type A

Dose 4

Experimental group

Description:

Dose 4

Treatment:

Biological: Botulinum Toxin, Type A

Biological: Botulinum Toxin Type A

Dose 5

Experimental group

Description:

Dose 5

Treatment:

Biological: Botulinum Toxin, Type A

Biological: Botulinum Toxin Type A