Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet
This study has been completed.
Sponsor:
Anterios Inc.
Information provided by (Responsible Party):
Anterios Inc.
ClinicalTrials.gov Identifier:
NCT01358695
First received: May 20, 2011
Last updated: January 23, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lateral Canthal Lines Crow's Feet |
Biological: ANT-1207 Biological: Botulinum Toxin, Type A Biological: Botulinum Toxin Type A |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines |
Resource links provided by NLM:
Further study details as provided by Anterios Inc.:
Primary Outcome Measures:
- Efficacy will be assessed by Investigator's Global Assessment Score [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Wrinkle scale with definitions of severity
Secondary Outcome Measures:
- Subject Self Assessment (SSA) scale [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]Change from Baseline in the Subject Self Assessment scale
- Investigator Global Assessment scale [ Time Frame: Week 1, 2, 4, 8, 12 ] [ Designated as safety issue: No ]Change from Baseline in wrinkle scale assessment at all other timepoints
| Enrollment: | 111 |
| Study Start Date: | May 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo Comparator |
Biological: ANT-1207
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.
|
|
Experimental: Dose 1
Dose 1
|
Biological: ANT-1207
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.
|
|
Experimental: Dose 2
Dose 2
|
Biological: ANT-1207
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.
|
|
Experimental: Dose 3
Dose 3
|
Biological: ANT-1207
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.
|
|
Experimental: Dose 4
Dose 4
|
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.
|
|
Experimental: Dose 5
Dose 5
|
Biological: Botulinum Toxin, Type A
The interventions differ by dose of investigational product applied.
Biological: Botulinum Toxin Type A
The interventions differ by dose of investigational product applied.
|
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358695
Locations
| United States, Alabama | |
| Total Skin & Beauty Dermatology Center | |
| Birmingham, Alabama, United States, 35205 | |
| United States, Florida | |
| Baumann Cosmetic & Research Institute | |
| Miami Beach, Florida, United States, 33140 | |
| Palm Beach Esthetic Dermatology and Laser Center | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Louisiana | |
| William Coleman III, MD, APMC | |
| Metairie, Louisiana, United States, 70006 | |
| United States, New York | |
| Gramercy Park Dermatology | |
| New York, New York, United States, 10010 | |
| United States, North Carolina | |
| Cary Skin Care | |
| Cary, North Carolina, United States, 27519 | |
Sponsors and Collaborators
Anterios Inc.
More Information
No publications provided
| Responsible Party: | Anterios Inc. |
| ClinicalTrials.gov Identifier: | NCT01358695 History of Changes |
| Other Study ID Numbers: | ANT-1207-201-LCL |
| Study First Received: | May 20, 2011 |
| Last Updated: | January 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Anterios Inc.:
|
Lateral Canthal Lines Crow's Feet |
Additional relevant MeSH terms:
|
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013