Lateral Canthal LinesPhase 2NCT01809964
Clinical Trial to Evaluate ANT-1401 in Crow's Feet
A Phase 2 study testing ANT-1401 in people with Lateral Canthal Lines and Crows Feet, run by Anterios Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines. 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, Crows Feet
- What is being tested?
- ANT-1401
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2013to Oct 2013
- 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 (IGA 1-2) at rest
- moderate to severe Crow's Feet (IGA 2-3) on contraction
- moderate to severe Crow's Feet (SSA 2-3) on contraction
- Have adequate vision to assess facial wrinkles in a mirror
Who cannot join
- botulinum toxin treatment in the prior 6 months
- history of periocular surgery, brow lift or related procedures
- soft tissue augmentation in the lateral canthal region in the prior 12 months
- dermabrasion or laser treatment in the periocular region in the last 6 months
- topical prescription-strength retinoids in the prior 3 months
- present or history of neuromuscular disease
- present or history of "dry eye"
- systemic aminoglycoside use in the week prior to treatment application
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Study site
Birmingham, Alabama, 35205
Study site
Knoxville, Tennessee, 37922
Study site
Louisville, Kentucky, 40202
Study site
Metairie, Louisiana, 70006
Study site
Miami, Florida, 33137
Study site
Pinellas Park, Florida, 33781
Study site
West Palm Beach, Florida, 33401
About this study
Official title: Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
The purpose of this study is to confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.
- Conditions
- Lateral Canthal Lines, Crows Feet
- Being tested
- ANT-1401, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANT-1401Biological
VehicleBiological
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | ANT-1401 Receives: Biological: ANT-1401 |
| Dose 2 | Experimental | ANT-1401 Receives: Biological: ANT-1401 |
| Vehicle | Placebo comparator | Placebo Vehicle Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment Scale
Measured: Week 4
Secondary outcomes (1)
Subject Self-Assessment
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionOct 2013
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
- 109 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
- NCT01809964
- Sponsor's protocol ID
- ANT-1401-LCL-203
- Status last verified
- Dec 2013
- First submitted
- 7 Mar 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate ANT-1401 in Subjects With Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT01809964
- Acronym / sponsor ID
- ANT-1401-LCL-203
- Conditions
- Lateral Canthal Lines, Crows Feet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Anterios Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Mar 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 confirm the effect of ANT-1401 in the treatment of Lateral Canthal Lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Biological: ANT-1401ANT-1401 |
| Dose 2 | Experimental | Biological: ANT-1401ANT-1401 |
| Vehicle | Placebo comparator | Biological: VehiclePlacebo Vehicle |
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 (IGA 1-2) at rest
- moderate to severe Crow's Feet (IGA 2-3) on contraction
- moderate to severe Crow's Feet (SSA 2-3) on contraction
- Have adequate vision to assess facial wrinkles in a mirror
Key exclusion criteria (8 listed)
- botulinum toxin treatment in the prior 6 months
- history of periocular surgery, brow lift or related procedures
- soft tissue augmentation in the lateral canthal region in the prior 12 months
- dermabrasion or laser treatment in the periocular region in the last 6 months
- topical prescription-strength retinoids in the prior 3 months
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-1401 | Biological | Dose 1, Dose 2 |
| Vehicle | Biological | Vehicle |
Primary outcome
Investigator's Global Assessment Scale
Time frame: Week 4
1 secondary outcome
Subject Self-Assessment
Time frame: Week 4
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 10 Jan 2014.
Related trials for Lateral Canthal Lines
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Not yet recruitingPhase 4
A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines
Active, not recruitingPhase 1
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
Skin Roughness, Wrinkle
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.
7 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 Crows Feet, run by Anterios Inc. at 7 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 8 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 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Investigator's 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 10 Jan 2014.