- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03326856
ET-01 in Subjects With Lateral Canthal Lines
April 19, 2022 updated by: Eirion Therapeutics Inc.
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.
Study Type
Interventional
Enrollment (Actual)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Cary, North Carolina, United States, 27519
- Cary Skin Care
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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-
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Vehicle
|
Vehicle Formulation
|
Experimental: Dose 1
botulinum toxin, Type A, Dose 1
|
topical liniment
Other Names:
|
Experimental: Dose 2
botulinum toxin, Type A, Dose 2
|
topical liniment
Other Names:
|
Experimental: Dose 3
botulinum toxin, Type A, Dose 3
|
topical liniment
Other Names:
|
Experimental: Dose 4
botulinum toxin, Type A, Dose 4
|
topical liniment
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Response Defined as IGA-C (Investigators Global Assessment) Score ≤ 2 and a SSA-C (Subject Self-Assessment) Score ≤ 2
Time Frame: Week 4
|
Composite of Investigators Global Assessment & Subject Self-Assessment on contraction. Crow's Feet Wrinkle Scale where severity is scored between 0-4 (0=absent; 4=severe). The same scale is used for the Investigator's Assessment as well as the Subject's Self Assessment. To count, both assessments (on contraction) have to be "responders" defined as Score ≤ 2. |
Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total Number of Observations With a Response Defined as IGA-C Score ≤ 2
Time Frame: Week 2, 4, 8,12,18
|
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.
|
Week 2, 4, 8,12,18
|
Total Number of Observations With a Response Defined as SSA-C Score ≤ 2
Time Frame: Week 2, 4, 8,12,18
|
Total number of observations with a Score of ≤ 2 on 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 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.
|
Week 2, 4, 8,12,18
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Klaus Theobald, MD, PhD, Eirion Therapeutics
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2017
Primary Completion (Actual)
June 11, 2018
Study Completion (Actual)
November 14, 2018
Study Registration Dates
First Submitted
October 27, 2017
First Submitted That Met QC Criteria
October 27, 2017
First Posted (Actual)
October 31, 2017
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ET-01-LCL-206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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