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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01358695
Other study ID # ANT-1207-201-LCL
Secondary ID
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


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
See also
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Completed NCT01809964 - Clinical Trial to Evaluate ANT-1401 in Crow's Feet Phase 2
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Completed NCT04225260 - Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines Phase 3
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