Lateral Canthal LinesPhase 2NCT01951742
Dose Finding Study In Subjects With Crow's Feet
A Phase 2 study testing ANT-1401 in people with Lateral Canthal Lines and Crow's Feet, run by Anterios Inc. at 10 sites in United States.
Trial summary
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lateral Canthal Lines, Crow's Feet
- What is being tested?
- ANT-1401
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 10 sitesUnited States
- Study dates
- Sep 2013to Jan 2014
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 30 - 60 years of age
- mild to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet wrinkles 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Study site
Chicago, Illinois, 60611
Study site
High Point, North Carolina, 27262
Study site
Knoxville, Tennessee, 37922
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33137
Study site
New Orleans, Louisiana, 70124
Study site
Norfolk, Virginia, 23507
Study site
Pinellas Park, Florida, 33781
Study site
Rochester, New York, 14623
Study site
West Palm Beach, Florida, 33401
About this study
Official title: Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
The purpose of this study is to establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
- Conditions
- Lateral Canthal Lines, Crow's Feet
- Being tested
- ANT-1401, Vehicle
- Keywords
- wrinkles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-1401Biological
Active
VehicleBiological
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | vehicle without ANT-1401 Receives: Biological: Vehicle |
| Dose 1 | Experimental | lowest dose Receives: Biological: ANT-1401 |
| Dose 2 | Experimental | second lowest dose Receives: Biological: ANT-1401 |
| Dose 3 | Experimental | mid-level dose Receives: Biological: ANT-1401 |
| Dose 4 | Experimental | second highest dose Receives: Biological: ANT-1401 |
| Dose 5 | Experimental | highest dose Receives: Biological: ANT-1401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators Global Assessment Scale
Crow's Feet Wrinkle Scale
Measured: Week 4
Secondary outcomes (1)
Subject Self-Assessment score
Subjects self assessment of severity of Crow's Feet
Measured: up to 12 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionJan 2014
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 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
- NCT01951742
- Sponsor's protocol ID
- ANT-1401-LCL-204
- Status last verified
- May 2014
- First submitted
- 22 Sep 2013
- Last updated
- 29 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Finding Study of Botulinum Neurotoxin Type A In Subjects With Crow's Feet (Lateral Canthal Lines)
- ClinicalTrials.gov ID
- NCT01951742
- Acronym / sponsor ID
- ANT-1401-LCL-204
- Conditions
- Lateral Canthal Lines, Crow's Feet
- Keywords
- wrinkles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Anterios Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Sep 2013 (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 establish the therapeutic range of ANT-1401 in the treatment of Crow's Feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Biological: Vehiclevehicle without ANT-1401 |
| Dose 1 | Experimental | Biological: ANT-1401lowest dose |
| Dose 2 | Experimental | Biological: ANT-1401second lowest dose |
| Dose 3 | Experimental | Biological: ANT-1401mid-level dose |
| Dose 4 | Experimental | Biological: ANT-1401second highest dose |
| Dose 5 | Experimental | Biological: ANT-1401highest dose |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 30 - 60 years of age
- mild to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet wrinkles 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-1401Active | Biological | Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 |
| VehicleVehicle | Biological | Vehicle |
Primary outcome
Investigators Global Assessment Scale
Time frame: Week 4
Crow's Feet Wrinkle Scale
1 secondary outcome
Subject Self-Assessment score
Time frame: up to 12 12 weeks
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 29 May 2014.
Related trials for Lateral Canthal Lines
Active, not recruitingObservational study
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A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
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A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
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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.
10 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-1401 in people with Lateral Canthal Lines and Crow's Feet, run by Anterios Inc. at 10 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 5 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 29 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Investigators Global Assessment Scale (time frame: Week 4). 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 29 May 2014.