Lateral Canthal Lines, LCLPhase 2NCT03912805
ET-01 in Subjects With Lateral Canthal Lines, LCL-209
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 3 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, women only
- 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
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2019to 4 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females 25 - 65 years of age
- minimal to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet on contraction
- adequate vision to assess facial wrinkles in a mirror
- willingness to refrain from products affecting skin remodeling
- female subjects must be not pregnant and non-lactating
- subjects should be in good general health
Who cannot join
- history of adverse reactions to any prior botulinum toxin treatments
- history of vaccination or non-response to any prior botulinum toxin treatments
- botulinum toxin treatment in the prior 6 months
- present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
- 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
3 sites in 1 country.
United States3 sites
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Synexis, Inc.
Pinellas Park, Florida, 33781
Yardley Dermatology Associates
Yardley, Pennsylvania, 19067
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
- botulinum toxin, Type A, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin, Type ABiological
Also called ET-01 1610U
topical liniment
VehicleBiological
Vehicle Formulation
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle, topical liniment, administered once at baseline Receives: Biological: Vehicle |
| ET-01 1610U | Experimental | botulinum toxin, Type A, topical liniment, administered once at baseline Receives: Biological: botulinum toxin, Type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
Measured: Week 4
Secondary outcomes (2)
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
Total number of observations with a change in the Investigators Global Assessment on Contraction, IGA-C, and the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
Measured: Week 1, 2, 4, 8,12,18, and 26
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit
Total number of observations with a change in the Subject Self-Assessment on Contraction, SSA-C, using the Crow's Feet Wrinkle Scale, where severity is scored between 0-4 (0=absent; 4=severe). To count, a "responder" is defined as a change by at least two ordinals in both assessments. The observation period includes all post-baseline visits from Week 1 to Week 26.
Measured: Week 1, 2, 4, 8,12,18, and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start27 Feb 2019
- Primary completion6 May 2019
- Study completion4 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 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
- NCT03912805
- Sponsor's protocol ID
- ET-01-LCL-209
- Status last verified
- Jul 2022
- First submitted
- 10 Apr 2019
- Last updated
- 28 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 28 Jul 2022. 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
- NCT03912805
- Acronym / sponsor ID
- ET-01-LCL-209
- Conditions
- Lateral Canthal Lines, LCL, Crow's Feet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Eirion Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2019 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 4 Oct 2019 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Posted 24 Jun 2022
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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- vehicle controlled, parallel group
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Biological: VehicleVehicle, topical liniment, administered once at baseline |
| ET-01 1610U | Experimental | Biological: botulinum toxin, Type Abotulinum toxin, Type A, topical liniment, administered once at baseline |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- females 25 - 65 years of age
- minimal to moderate Crow's Feet wrinkles at rest
- moderate to severe Crow's Feet on contraction
- adequate vision to assess facial wrinkles in a mirror
- willingness to refrain from products affecting skin remodeling
Key exclusion criteria (8 listed)
- history of adverse reactions to any prior botulinum toxin treatments
- history of vaccination or non-response to any prior botulinum toxin treatments
- botulinum toxin treatment in the prior 6 months
- present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
- history of peri-ocular surgery, brow lift or related procedures
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 |
|---|---|---|
| botulinum toxin, Type AAlso: ET-01 1610Utopical liniment | Biological | ET-01 1610U |
| VehicleVehicle Formulation | Biological | Vehicle |
Primary outcome
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4
Time frame: Week 4
Investigators Global Assessment of the Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). Response is defined as change by at least two ordinals from Baseline to Week 4.
2 secondary outcomes
Total Number of Observations With a Response Defined as Change ≥2 in IGA-C and SSA-C Score at Any Post Baseline Visit
Time frame: Week 1, 2, 4, 8,12,18, and 26
Total Number of Observations With a Response Defined as Change in SSA-C Score ≥ 2 at Any Post Baseline Visit
Time frame: Week 1, 2, 4, 8,12,18, and 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
3 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 3 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 7 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 24 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With a Response Defined as Change in IGA-C (Investigators Global Assessment) Score by at Least 2 Ordinals From Baseline to Week 4 (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 28 Jul 2022.