Lateral Canthal LinesPhase 2NCT03655691
ET-01 in Subjects With Lateral Canthal Lines, LCL-207
A Phase 2 study testing botulinum toxin, Type A in people with Lateral Canthal Lines and Crow's Feet, run by Eirion Therapeutics Inc. at 6 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, 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
- 79 participants
- Where
- 6 sitesUnited States
- Study dates
- 16 Aug 2018to 11 Apr 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 - 65 years of age
- minimal 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 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
Dermatology NOLA Inc.
Metairie, Louisiana, 70006
Baumann Cosmetic & Research Institute
Miami, Florida, 33137
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23502
Radiant Research, Inc.
Pinellas Park, Florida, 33781
Research Institute of the Southeast, LLC
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, also known as Crow's Feet.
- Conditions
- Lateral Canthal Lines, 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
Vehicle Formulation
botulinum toxin, Type ABiological
Also called ET-01
botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline
botulinum toxin, Type ABiological
Also called ET-01
botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Vehicle / Placebo formulation Receives: Biological: Vehicle |
| Dose 1 | Experimental | lower dose of ET-01 Receives: Biological: botulinum toxin, Type A |
| Dose 2 | Experimental | higher dose of ET-01 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 IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
Total number of observations with a Score of ≤ 2 on the Investigators Global Assessment on Contraction, IGA-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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
Measured: Week 2, 4, 8,12, and 18
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
Total number of observations with a Score of ≤ 2 on the Subjects 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 Score ≤ 2. The observation period ranges from the earliest expected onset of action at Week 2 to the likely offset of action by Week 18.
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 posted31 Aug 2018
- Study start16 Aug 2018
- Primary completion9 Nov 2018
- Study completion11 Apr 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 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
- Model description
- parallel dose groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eirion Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus Theobald, MD, PhD, Study director, Eirion Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655691
- Sponsor's protocol ID
- ET-01-LCL-207
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2018
- Last updated
- 21 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Apr 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
- NCT03655691
- Acronym / sponsor ID
- ET-01-LCL-207
- Conditions
- Lateral Canthal Lines, Crow's Feet
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Eirion Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 11 Apr 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 18 Feb 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, 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
- 3
- Model description
- parallel dose groups
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Biological: VehicleVehicle / Placebo formulation |
| Dose 1 | Experimental | Biological: botulinum toxin, Type Alower dose of ET-01 |
| Dose 2 | Experimental | Biological: botulinum toxin, Type Ahigher dose of ET-01 |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 25 - 65 years of age
- minimal 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 (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 |
|---|---|---|
| VehicleVehicle Formulation | Biological | Vehicle |
| botulinum toxin, Type AAlso: ET-01botulinum toxin, Type A, lower Dose 1, administered once, topically, at Baseline | Biological | Dose 1 |
| botulinum toxin, Type AAlso: ET-01botulinum toxin, Type A, higher Dose 2, administered once, topically, at Baseline | Biological | Dose 2 |
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 IGA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
Time frame: Week 2, 4, 8,12, and 18
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2 at Any Time Between Week 2 and Week 18
Time frame: Week 2, 4, 8,12, and 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Lateral Canthal Lines
Not yet recruitingPhase 2
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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.
Klaus Theobald, MD, PhD study director
Eirion Therapeutics
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 botulinum toxin, Type A in people with Lateral Canthal Lines and Crow's Feet, run by Eirion Therapeutics 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 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 21 Apr 2022. 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?
Yes. Results are posted in the registry (first posted 18 Feb 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 21 Apr 2022.