Crow's Feet, Lateral Canthal Lines
Conditions
Keywords
Lateral Canthal Lines, Crow's Feet
Brief summary
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.
Interventions
BIOLOGICALANT-1207
The interventions differ by dose of investigational product applied.
BIOLOGICALBotulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
BIOLOGICALBotulinum Toxin Type A
The interventions differ by dose of investigational product applied.
Sponsors
Anterios Inc.
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy will be assessed by Investigator's Global Assessment Score | 2 weeks | Wrinkle scale with definitions of severity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Self Assessment (SSA) scale | 2 Weeks | Change from Baseline in the Subject Self Assessment scale |
| Investigator Global Assessment scale | Week 1, 2, 4, 8, 12 | Change from Baseline in wrinkle scale assessment at all other timepoints |
Countries
United States
Outcome results
None listed