Lateral Canthal Lines, LCLPhase 2NCT04985916
ET-01 in Subjects With Lateral Canthal Lines, LCL-210
A Phase 2 study testing botulinum toxin, Type A in people with Lateral Canthal Lines, LCL and Crow's Feet, run by Eirion Therapeutics Inc. at 19 sites in United States.
Trial summary
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL). Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Lateral Canthal Lines, LCL, Crow's Feet
- What is being tested?
- botulinum toxin, Type A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 19 sitesUnited States
- Study dates
- 19 Jul 2021to 8 Feb 2024
- 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- able to understand and give written informed consent
- 25 - 65 years of age
- willing to have facial pictures/videos taken per protocol
- mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"
- moderate to severe Crow's Feet (IGA 3-4) "on contraction"
- ability to correctly grade a series of Crow's Feet pictures
Show all 12Show fewer
- moderate to severe Crow's Feet (SSA 3-4) "on contraction"
- have adequate vision without the use of eyeglasses to assess facial wrinkles in a mirror (contact lenses are OK)
- willingness to refrain from the use of facial fillers, retinoids, botulinum toxins, laser treatments, or any product affecting skin remodeling or that might cause an active dermal response during the course of the study
- female subjects of childbearing potential must have a negative urine pregnancy test and be non-lactating at the Baseline visit
- female subjects of childbearing potential must utilize one of the following methods of birth control throughout the study: intra-uterine device (IUD), diaphragm, a condom, a spermicidal gel or foam, oral contraceptives (provided subject has been utilizing this method for at least 3 months prior to Baseline and has not changed the brand within this period), or patch, injectable, implantable, or vaginal ring contraceptives. Subjects may also participate if they are surgically sterilized (tubal sterilization or hysterectomy) or are in menopause.
- subjects should be in good general health as determined by the Investigator and free of any disease that may interfere with study evaluations or the Investigational Product.
Who cannot join
- history of adverse reactions to any prior botulinum toxin treatments
- history of vaccination with botulinum toxin
- history of non-response to any prior botulinum toxin treatments
- any botulinum toxin treatment anywhere in the prior 6 months
- history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time in the past
- history of periocular surgery, brow lift or related procedures
Show all 19Show fewer
- soft tissue augmentation or any procedures affecting 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 to the treatment area
- application of any topical prescription medication to the treatment area within 14 days prior to treatment
- subjects on clinically significant, concomitant drug therapy (See Section 5.3 below).).
- present or history of neuromuscular disease, eyelid ptosis, muscle weakness or paralysis
- present or history of "dry eye"
- hemophilia, hemorrhagic disorder, hemostatic dysfunction or other blood clotting disorders
- use of systemic aminoglycosides in the week prior to treatment application
- participation in another investigational drug trial or receiving any investigational treatment(s) within 30 days of Baseline
- alcohol or drug abuse within the past 3 years
- psychiatric disease interfering with the subject's ability to give informed consent
- refusal or inability to comply with the requirements of the protocol for any reason
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Eirion Research Site
Aventura, Florida, 33180
Eirion Research Site
Boca Raton, Florida, 33486
Eirion Research Site
Chicago, Illinois, 60654
Eirion Research Site
Clinton Township, Michigan, 48038
Eirion Research Site
Exton, Pennsylvania, 19341
Eirion Research Site
Glenn Dale, Maryland, 20769
Eirion Research Site
Greenville, South Carolina, 29615
Eirion Research Site
Houston, Texas, 77056
Eirion Research Site
Louisville, Kentucky, 40241
Eirion Research Site
Miami, Florida, 33137
Eirion Research Site
New Brighton, Minnesota, 55112
Eirion Research Site
New Orleans, Louisiana, 70124
Eirion Research Site
New York, New York, 10075
Eirion Research Site
Newtown Square, Pennsylvania, 19073
Eirion Research Site
Norfolk, Virginia, 23502
Eirion Research Site
Plano, Texas, 75093
Eirion Research Site
San Diego, California, 92121
Eirion Research Site
Scottsdale, Arizona, 85255
Eirion Research Site
West Palm Beach, Florida, 33401
About this study
Official title: Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Read the detailed description
This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.
- Conditions
- Lateral Canthal Lines, LCL, Crow's Feet
- Being tested
- Vehicle, botulinum toxin, Type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VehicleBiological
Also called ET-01 Vehicle
topical liniment without investigational product
botulinum toxin, Type ABiological
Also called ET-01
ET-01 topical liniment
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle, topical liniment, administered once at baseline Receives: Biological: Vehicle |
| ET-01, Dose 1 | Experimental | Dose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length Receives: Biological: botulinum toxin, Type A |
| ET-01, Dose 2 | Experimental | Dose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length Receives: Biological: botulinum toxin, Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA (Investigators Global Assessment)
Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).
Measured: Week 4
Secondary outcomes (2)
IGA (Investigators Global Assessment)
Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).
Measured: Week 2, 4, 8,12, and 18
SSA (Subject Self-Assessment)
Subject Self-Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).
Measured: Week 2, 4, 8,12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start19 Jul 2021
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Canthal Lines, LCLStudies 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
- Model description
- vehicle controlled, parallel group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eirion Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985916
- Sponsor's protocol ID
- ET-01-LCL-210
- Status last verified
- Dec 2024
- First submitted
- 22 Jul 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Evaluate ET-01 in Subjects With Lateral Canthal Lines
- ClinicalTrials.gov ID
- NCT04985916
- Acronym / sponsor ID
- ET-01-LCL-210
- Conditions
- Lateral Canthal Lines, LCL, Crow's Feet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Eirion Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 2 Aug 2021 (actual)
- 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.
This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).
Detailed description
This product is being tested for its ability to reduce lateral canthal lines (LCL), also known as Crow's Feet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- vehicle controlled, parallel group
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Biological: VehicleVehicle, topical liniment, administered once at baseline |
| ET-01, Dose 1 | Experimental | Biological: botulinum toxin, Type ADose 1 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length |
| ET-01, Dose 2 | Experimental | Biological: botulinum toxin, Type ADose 2 of botulinum toxin, Type A, topical liniment, administered once at baseline. 250µm microneedle length |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- able to understand and give written informed consent
- 25 - 65 years of age
- willing to have facial pictures/videos taken per protocol
- mild or less Crow's Feet wrinkles (IGA 0-2) "at rest"
- moderate to severe Crow's Feet (IGA 3-4) "on contraction"
Key exclusion criteria (19 listed)
- history of adverse reactions to any prior botulinum toxin treatments
- history of vaccination with botulinum toxin
- history of non-response to any prior botulinum toxin treatments
- any botulinum toxin treatment anywhere in the prior 6 months
- history of participation in ET-01-LCL-210 in previous Cohorts 1 or 2 at any time in the past
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 |
|---|---|---|
| VehicleAlso: ET-01 Vehicletopical liniment without investigational product | Biological | Vehicle |
| botulinum toxin, Type AAlso: ET-01ET-01 topical liniment | Biological | ET-01, Dose 1, ET-01, Dose 2 |
Primary outcome
IGA (Investigators Global Assessment)
Time frame: Week 4
Investigators Global Assessment. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe).
2 secondary outcomes
IGA (Investigators Global Assessment)
Time frame: Week 2, 4, 8,12, and 18
SSA (Subject Self-Assessment)
Time frame: Week 2, 4, 8,12, and 18
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 9 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Lateral Canthal Lines, LCL
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
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.
19 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 botulinum toxin, Type A in people with Lateral Canthal Lines, LCL and Crow's Feet, run by Eirion Therapeutics Inc. at 19 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 12 inclusion and 19 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 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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?
IGA (Investigators Global Assessment) (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 9 Dec 2024.