ET-01 in Subjects With Lateral Canthal Lines, LCL-208

Eirion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Lateral Canthal Lines; Crow's Feet

Treatments: Biological: botulinum toxin, Type A; Biological: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03839693

ET-01-LCL-208

Details and patient eligibility

About

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

Full description

This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Enrollment: 75 patients

Sex: Female

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• females 25 - 65 years of age
• minimal to moderate Crow's Feet wrinkles at rest
• moderate to severe Crow's Feet on contraction
• adequate vision to assess facial wrinkles in a mirror
• willingness to refrain from products affecting skin remodeling
• female subjects must be not pregnant and non-lactating
• subjects should be in good general health

Exclusion criteria

• history of adverse reactions to any prior botulinum toxin treatments
• history of vaccination or non-response to any prior botulinum toxin treatments
• botulinum toxin treatment in the prior 6 months
• present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
• 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: Sequential Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups, including a placebo group

Vehicle

Placebo Comparator group

Description:

Vehicle

Treatment:

Biological: Vehicle

ET-01 345U

Experimental group

Description:

botulinum toxin, Type A, Dose 1, 345 U

Treatment:

Biological: botulinum toxin, Type A

ET-01 1100U

Experimental group

Description:

botulinum toxin, Type A, Dose 2, 1100 U

Treatment:

Biological: botulinum toxin, Type A