Lateral Canthal LinesPhase 2NCT01358695
Clinical Trial To Evaluate ANT-1207 In Subjects With Crow's Feet
A Phase 2 study testing ANT-1207, Botulinum Toxin, Type A and Botulinum Toxin Type A in people with Lateral Canthal Lines and Crow's Feet, run by Anterios Inc. at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Canthal Lines, Crow's Feet
- What is being tested?
- ANT-1207, Botulinum Toxin, Type A and Botulinum Toxin Type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2011to May 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
Cary Skin Care
Cary, North Carolina, 27519
William Coleman III, MD, APMC
Metairie, Louisiana, 70006
Baumann Cosmetic & Research Institute
Miami Beach, Florida, 33140
Gramercy Park Dermatology
New York, New York, 10010
Palm Beach Esthetic Dermatology and Laser Center
West Palm Beach, Florida, 33401
About this study
Official title: Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines
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.
- Conditions
- Lateral Canthal Lines, Crow's Feet
- Being tested
- ANT-1207, Botulinum Toxin, Type A, Botulinum Toxin Type A
- Keywords
- Lateral Canthal Lines, Crow's Feet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-1207Biological
The interventions differ by dose of investigational product applied.
Botulinum Toxin, Type ABiological
The interventions differ by dose of investigational product applied.
Botulinum Toxin Type ABiological
The interventions differ by dose of investigational product applied.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Comparator | Placebo comparator | Not described Receives: Biological: ANT-1207; Biological: Botulinum Toxin Type A |
| Dose 1 | Experimental | Dose 1 Receives: Biological: ANT-1207; Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A |
| Dose 2 | Experimental | Dose 2 Receives: Biological: ANT-1207; Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A |
| Dose 3 | Experimental | Dose 3 Receives: Biological: ANT-1207; Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A |
| Dose 4 | Experimental | Dose 4 Receives: Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A |
| Dose 5 | Experimental | Dose 5 Receives: Biological: Botulinum Toxin, Type A; Biological: Botulinum Toxin Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy will be assessed by Investigator's Global Assessment Score
Wrinkle scale with definitions of severity
Measured: 2 weeks
Secondary outcomes (2)
Subject Self Assessment (SSA) scale
Change from Baseline in the Subject Self Assessment scale
Measured: 2 Weeks
Investigator Global Assessment scale
Change from Baseline in wrinkle scale assessment at all other timepoints
Measured: Week 1, 2, 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterios Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358695
- Sponsor's protocol ID
- ANT-1207-201-LCL
- Status last verified
- Jun 2013
- First submitted
- 20 May 2011
- Last updated
- 1 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial To Evaluate ANT-1207 In Subjects With Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT01358695
- Acronym / sponsor ID
- ANT-1207-201-LCL
- Conditions
- Lateral Canthal Lines, Crow's Feet
- Keywords
- Lateral Canthal Lines, Crow's Feet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Anterios Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 24 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo Comparator | Placebo comparator | Biological: ANT-1207, Biological: Botulinum Toxin Type A |
| Dose 1 | Experimental | Biological: ANT-1207, Biological: Botulinum Toxin, Type A, Biological: Botulinum Toxin Type ADose 1 |
| Dose 2 | Experimental | Biological: ANT-1207, Biological: Botulinum Toxin, Type A, Biological: Botulinum Toxin Type ADose 2 |
| Dose 3 | Experimental | Biological: ANT-1207, Biological: Botulinum Toxin, Type A, Biological: Botulinum Toxin Type ADose 3 |
| Dose 4 | Experimental | Biological: Botulinum Toxin, Type A, Biological: Botulinum Toxin Type ADose 4 |
| Dose 5 | Experimental | Biological: Botulinum Toxin, Type A, Biological: Botulinum Toxin Type ADose 5 |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANT-1207The interventions differ by dose of investigational product applied. | Biological | Dose 1, Dose 2, Dose 3, Placebo Comparator |
| Botulinum Toxin, Type AThe interventions differ by dose of investigational product applied. | Biological | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 |
| Botulinum Toxin Type AThe interventions differ by dose of investigational product applied. | Biological | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Placebo Comparator |
Primary outcome
Efficacy will be assessed by Investigator's Global Assessment Score
Time frame: 2 weeks
Wrinkle scale with definitions of severity
2 secondary outcomes
Subject Self Assessment (SSA) scale
Time frame: 2 Weeks
Investigator Global Assessment scale
Time frame: Week 1, 2, 4, 8, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2013.
Related trials for Lateral Canthal Lines
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANT-1207, Botulinum Toxin, Type A and Botulinum Toxin Type A in people with Lateral Canthal Lines and Crow's Feet, run by Anterios Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy will be assessed by Investigator's Global Assessment Score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2013.