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

Lateral Canthal Lines Clinical Trial

Official title:

Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358695
• Other study ID #: ANT-1207-201-LCL
• Status: Completed
• Phase: Phase 2
• First received: May 20, 2011
• Last updated: June 21, 2013
• Start date: May 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2013
• Source: Anterios Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: May 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crow's Feet
• Lateral Canthal Lines

Intervention

Biological:
• ANT-1207
The interventions differ by dose of investigational product applied.
• Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
• Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.

Locations

Country	Name	City	State
United States	Total Skin & Beauty Dermatology Center	Birmingham	Alabama
United States	Cary Skin Care	Cary	North Carolina
United States	William Coleman III, MD, APMC	Metairie	Louisiana
United States	Baumann Cosmetic & Research Institute	Miami Beach	Florida
United States	Gramercy Park Dermatology	New York	New York
United States	Palm Beach Esthetic Dermatology and Laser Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Anterios Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy will be assessed by Investigator's Global Assessment Score	Wrinkle scale with definitions of severity	2 weeks	No
Secondary	Subject Self Assessment (SSA) scale	Change from Baseline in the Subject Self Assessment scale	2 Weeks	No
Secondary	Investigator Global Assessment scale	Change from Baseline in wrinkle scale assessment at all other timepoints	Week 1, 2, 4, 8, 12	No