Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines? (toxin)
Effect of Sequential trenibotulinumtoxinE on the Duration of onabotulinumtoxinA Effect in Lateral Canthal Lines: An Exploratory, Randomized, Placebo-Controlled, Split-Face Pilot Study
This pilot study will look at whether trenibotulinumtoxinE can shorten or reverse the effect of onabotulinumtoxinA in people being treated for lateral canthal lines (also called crow's feet). OnabotulinumtoxinA is a commonly used treatment that relaxes the muscles around the eyes and smooths these lines, and its effect usually lasts about three to four months. Some people may want the effect to wear off sooner. This study will test whether giving trenibotulinumtoxinE after onabotulinumtoxinA changes how long the effect lasts.
Participants will receive onabotulinumtoxinA on both sides of the face. Using a split-face design, one side of each person's face will then be randomly assigned to receive trenibotulinumtoxinE and the other side will receive a placebo. This lets each person act as their own comparison. [Number] adults will take part, and they will be followed for [length of follow-up] to see how long the effect on each side of the face lasts. The main measure is [primary outcome, e.g., time until lateral canthal line severity returns to baseline on each side]. Safety and side effects will also be recorded.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Alain Michon, MD
- Phone Number: 613-745-7546
- Email: alain.michon@projectskinmd.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Inclusion criteria Adults aged 18 to 65 years. Moderate to severe lateral canthal lines (crow's feet) at maximum smile on both sides, bilaterally symmetrical, as rated by the investigator on the Facial Wrinkle Scale (grade 2 or 3).
Good general health, based on medical history and physical examination. Willing to receive onabotulinumtoxinA in both lateral canthal areas, accept random assignment of trenibotulinumtoxinE or saline to each side, and attend all study visits and photography.
Women of childbearing potential agree to use effective contraception during the study.
Written informed consent.
Exclusion Criteria:
- Any botulinum toxin (any serotype, any site) in the previous 6 months. Known hypersensitivity to any botulinum toxin or to the excipients, or a history of resistance or immunization to botulinum toxin.
Neuromuscular disease (myasthenia gravis, Lambert-Eaton syndrome, ALS, motor neuropathy) or any condition affecting neuromuscular function.
Use of medications that potentiate botulinum toxin (such as aminoglycosides, curare-like agents) in the past 4 weeks.
Facial nerve palsy, eyelid or brow ptosis, marked facial asymmetry, or excessive dermatochalasis.
Deep dermal scarring, or inability to substantially lessen the lines by spreading the skin apart.
Previous surgery of the periorbital area (blepharoplasty, brow lift), or fillers, laser resurfacing, deep peels, or other cosmetic procedures in the periorbital area in the past 6 to 12 months.
Active infection or skin disease at the injection sites. Pregnancy, breastfeeding, or planned pregnancy during the study. Anticoagulant therapy or a bleeding disorder (increased risk of bruising). Participation in another clinical trial within 30 days. Any condition that, in the investigator's opinion, could put the participant at risk or confound the results.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TrenibotulinumtoxinE Side
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. One side of the face, chosen at random, then receives trenibotulinumtoxinE. The other side receives placebo (see Placebo Side arm). |
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. One side of the face, chosen at random, then receives trenibotulinumtoxinE. The other side receives placebo (see Placebo Side arm). |
|
Placebo Comparator: Placebo Side
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo. |
OnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of OnabotulinumtoxinA Effect on Lateral Canthal Lines
Time Frame: From onabotulinumtoxinA injection through day 120.
|
Time in days from onabotulinumtoxinA injection until lateral canthal line severity at maximum smile returns to baseline (pre-treatment) severity, measured separately for each side of the face using [rating scale, e.g., the validated Facial Wrinkle Scale] by a blinded assessor. The duration will be compared between the side treated with trenibotulinumtoxinE and the side treated with placebo. |
From onabotulinumtoxinA injection through day 120.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Lateral Canthal Line Severity at Maximum Smile
Time Frame: From day 0 to day 120.
|
Change from baseline in severity on each side of the face, rated by a blinded assessor using Allergan Facial Wrinkle Scale. Compared between the trenibotulinumtoxinE side and the placebo side. |
From day 0 to day 120.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PS01-treni
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Individual participant data will not be shared. This pilot study includes only 4 participants, and the data include standardized facial photographs and detailed split-face assessments that cannot be adequately de-identified without a risk of re-identifying participants. Participants have not consented to public data sharing. Aggregate, de-identified results (individual-level descriptions without identifying information) will be reported in publications and in the ClinicalTrials.gov results section if applicable.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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