Wrinkles and RhytidesPhase 2toxinNCT07923448
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
A Phase 2 study testing TrenibotulinumtoxinE and OnabotulinumtoxinA in people with Wrinkles and Rhytides, run by Project Skin MD.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Wrinkles and Rhytides
- What is being tested?
- TrenibotulinumtoxinE and OnabotulinumtoxinA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Wrinkles and Rhytides
- Being tested
- TrenibotulinumtoxinE and OnabotulinumtoxinA, Onabotulinumtoxin A followed by placebo
- Keywords
- wrinkles, botulinumtoxinA, botulinumtoxinE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrenibotulinumtoxinE and OnabotulinumtoxinABiological
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).
Onabotulinumtoxin A followed by placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TrenibotulinumtoxinE Side | Experimental | 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). Receives: Biological: TrenibotulinumtoxinE and OnabotulinumtoxinA |
| Placebo Side | Placebo comparator | 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. Receives: Drug: Onabotulinumtoxin A followed by placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of OnabotulinumtoxinA Effect on Lateral Canthal Lines
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.
Measured: From onabotulinumtoxinA injection through day 120.
Secondary outcomes (1)
Change in Lateral Canthal Line Severity at Maximum Smile
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.
Measured: From day 0 to day 120.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkles and RhytidesStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Project Skin MD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alain Michon, Hopital Montfort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923448
- Sponsor's protocol ID
- PS01-treni
- Acronym
- toxin
- Status last verified
- Oct 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sequential trenibotulinumtoxinE on the Duration of onabotulinumtoxinA Effect in Lateral Canthal Lines: An Exploratory, Randomized, Placebo-Controlled, Split-Face Pilot Study
- ClinicalTrials.gov ID
- NCT07923448
- Acronym / sponsor ID
- toxin / PS01-treni
- Conditions
- Wrinkles and Rhytides
- Keywords
- wrinkles, botulinumtoxinA, botulinumtoxinE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Project Skin MDUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 6 Nov 2026 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TrenibotulinumtoxinE Side | Experimental | Biological: TrenibotulinumtoxinE and OnabotulinumtoxinAOnabotulinumtoxinA 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 Side | Placebo comparator | Drug: Onabotulinumtoxin A followed by placeboOnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| TrenibotulinumtoxinE and OnabotulinumtoxinAOnabotulinumtoxinA 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). | Biological | TrenibotulinumtoxinE Side |
| Onabotulinumtoxin A followed by placeboOnabotulinumtoxinA is injected into the lateral canthal lines on both sides of the face. The side of the face not assigned to trenibotulinumtoxinE receives placebo. | Drug | Placebo Side |
Primary outcome
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.
1 secondary outcome
Change in Lateral Canthal Line Severity at Maximum Smile
Time frame: From day 0 to day 120.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. 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.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TrenibotulinumtoxinE and OnabotulinumtoxinA in people with Wrinkles and Rhytides, run by Project Skin MD.
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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Michon, MD (613-745-7546, alain.michon@projectskinmd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of OnabotulinumtoxinA Effect on Lateral Canthal Lines (time frame: From onabotulinumtoxinA injection through day 120.). 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 6 Nov 2026.