Glabellar LinesNCT07374965
A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A
An observational study of Glabellar Lines and Forehead Lines, run by Yuvell at 1 site in Austria.
Trial summary
The goal of this observational study is to learn about the safety, tolerability, and effectiveness of Letibotulinumtoxin A for the holistic treatment of the upper face in adults under 75 years old with moderate to severe upper facial lines, including glabellar lines, forehead lines, and lateral canthal lines. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Lines, Forehead Lines, Crow's Feet
- What is being tested?
- Letybo®
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 29 Jan 2024to 9 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the clinic for such a treatment as part of routine clinical practice.
Who may be able to join
- 18 years or older at time of treatment.
- At least mild frown lines at maximum frown, mild dynamic forehead lines at maximum eyebrow elevation or mild crow's feet at maximum smile.
- Subject has a stable medical condition with no uncontrolled systemic disease.
- Willingness to participate in the routine follow - up after 2 weeks and 4 months and a signed informed consent form.
Who cannot join
- Pregnancy and breast feeding.
- Neuromuscular disease (e.g. myasthenia gravis, Eaton - Lambert syndrome).
- Known impairment of blood coagulation.
- Drooping eyelid.
- Known allergy to botulinum toxin or human albumin (blood protein).
- Presence of acute infection or inflammation at the proposed injection sites.
- Botulinumtoxin treatment in the upper face within the last 16 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Non-interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A
The goal of this observational study is to learn about the safety, tolerability, and effectiveness of Letibotulinumtoxin A for the holistic treatment of the upper face in adults under 75 years old with moderate to severe upper facial lines, including glabellar lines, forehead lines, and lateral canthal lines.
The main questions it aims to answer are:
Read more
- Does Letibotulinumtoxin A safely and effectively reduce the severity of glabellar lines, forehead lines, and lateral canthal lines in adults under 75?
- How well is the treatment tolerated in everyday clinical practice?
- What is the patient satisfaction with holistic upper face treatment using Letibotulinumtoxin A?
Participants will:
- receive Letibotulinumtoxin A injections in the upper face, including glabellar lines, forehead lines, and lateral canthal lines.
- be observed and followed up to assess the severity of wrinkles, duration of effect, and patient satisfaction.
- report any adverse effects experienced during or after treatment.
- Conditions
- Glabellar Lines, Forehead Lines, Crow's Feet, Canthal Lines
- Being tested
- Letybo®
- Keywords
- botulinum toxin A, facial wrinkles, aesthetic medicine, forehead lines, crow's feet, glabellar lines, canthal lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letybo®Drug
Also called BoNT/A, botulinum toxin A, Letibotulinumtoxin A
Drug is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with drug use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2
Proportion of subjects achieving a combined responder status, defined as an improvement of at least 1 point from baseline in all 3 treated facial regions at Week 2, as assessed by the investigator using the following validated photo-numeric scales:
- Vertical glabellar lines assessed at maximum frowning using the Facial Wrinkle Scale (FWS), a scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity.
- Forehead lines assessed at maximum eyebrow elevation using the Croma Dynamic Forehead Line Assessment Scale (CDFLAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity.
- Crow's feet assessed at maximum smiling using the Croma Dynamic Crow's Feet Assessment Scale (CDCFAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity.
A subject is considered a responder only if the ≥ 1-point improvement criterion is met for all 3 scales simultaneously.
Measured: Week 2
Secondary outcomes (5)
Change in vectorial skin displacement at maximum frowning assessed by three-dimensional (3D) surface imaging
Change from baseline in vectorial skin displacement at maximum frowning, measured at Week 2 and Week 16 using three-dimensional (3D) surface imaging technology.
Vectorial skin displacement is quantified by comparing 3D facial surface images captured at baseline and follow-up visits to assess the magnitude and direction of skin movement during maximum frowning.
Wrinkle severity at maximum frowning is additionally assessed by the investigator using the Facial Wrinkle Scale (FWS), a validated photo-numeric scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity, to provide clinical context for the imaging-based measurements.
Measured: Week 2, Week 16
Change in vectorial skin displacement during maximum frontalis muscle contraction assessed by three-dimensional (3D) surface imaging
Change from baseline in vectorial skin displacement during maximum frontalis muscle contraction, assessed at Week 2 and Week 16 using three-dimensional (3D) surface imaging technology.
Vectorial skin displacement is quantified by comparing 3D facial surface images obtained at baseline and follow-up visits to evaluate the magnitude and direction of skin movement over the forehead region during maximum frontalis muscle contraction.
Forehead wrinkle severity during maximum contraction is additionally assessed by the investigator using the Croma Dynamic Forehead Line Assessment Scale (CDFLAS), a validated photo-numeric scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity, to provide clinical context to the imaging-based measurements.
Measured: Week 2, Week 16
Change in vectorial skin displacement during maximum orbicularis oculi muscle contraction assessed by three-dimensional (3D) surface imaging
Change from baseline in vectorial skin displacement during maximum orbicularis oculi muscle contraction, assessed at Week 2 and Week 16 using three-dimensional (3D) surface imaging technology.
Vectorial skin displacement is quantified by comparing 3D facial surface images captured at baseline and follow-up visits to evaluate the magnitude and direction of skin movement in the periocular (crow's feet) region during maximum orbicularis oculi muscle contraction.
Wrinkle severity of the crow's feet during maximum contraction is additionally assessed by the investigator using the Croma Dynamic Crow's Feet Assessment Scale (CDCFAS), a validated photo-numeric scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity, to provide clinical context for the imaging-based displacement measurements.
Measured: Week 2, Week 16
Percentage of subjects requiring a touch-up at Week 2
Percentage of subjects who, in the opinion of the investigator, required a touch-up treatment at the Week 2 visit to optimize the treatment outcome.
The need for a touch-up is determined by the investigator based on clinical assessment.
Measured: Week 2
Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire
Patient satisfaction with the treatment as assessed by participants using the clinic-internal questionnaire titled "Patient Satisfaction Questionnaire".
The questionnaire consists of 5 questions evaluating the participant's overall satisfaction with the treatment outcome. Each item is rated on a numeric ordinal scale from 1 to 5, where lower scores indicate higher patient satisfaction.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start29 Jan 2024
- Primary completion16 May 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuvell
- Sponsor type
- University, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Responsible party
- Sponsor
- Investigators
- Nikolaus Duschek, Priv.-Doz., PhD, Principal investigator, Yuvell
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374965
- Sponsor's protocol ID
- YUV-NIS-001
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A
- ClinicalTrials.gov ID
- NCT07374965
- Acronym / sponsor ID
- YUV-NIS-001
- Conditions
- Glabellar Lines, Forehead Lines, Crow's Feet, Canthal Lines
- Keywords
- botulinum toxin A, facial wrinkles, aesthetic medicine, forehead lines, crow's feet, glabellar lines, canthal lines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- YuvellUniversity, hospital or other
- Collaborators
- Croma-Pharma GmbH
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 29 Jan 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.
The goal of this observational study is to learn about the safety, tolerability, and effectiveness of Letibotulinumtoxin A for the holistic treatment of the upper face in adults under 75 years old with moderate to severe upper facial lines, including glabellar lines, forehead lines, and lateral canthal lines.
The main questions it aims to answer are:
- Does Letibotulinumtoxin A safely and effectively reduce the severity of glabellar lines, forehead lines, and lateral canthal lines in adults under 75?
- How well is the treatment tolerated in everyday clinical practice?
- What is the patient satisfaction with holistic upper face treatment using Letibotulinumtoxin A?
Participants will:
- receive Letibotulinumtoxin A injections in the upper face, including glabellar lines, forehead lines, and lateral canthal lines.
- be observed and followed up to assess the severity of wrinkles, duration of effect, and patient satisfaction.
- report any adverse effects experienced during or after treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the clinic for such a treatment as part of routine clinical practice.
Key inclusion criteria (4 listed)
- 18 years or older at time of treatment.
- At least mild frown lines at maximum frown, mild dynamic forehead lines at maximum eyebrow elevation or mild crow's feet at maximum smile.
- Subject has a stable medical condition with no uncontrolled systemic disease.
- Willingness to participate in the routine follow - up after 2 weeks and 4 months and a signed informed consent form.
Key exclusion criteria (7 listed)
- Pregnancy and breast feeding.
- Neuromuscular disease (e.g. myasthenia gravis, Eaton - Lambert syndrome).
- Known impairment of blood coagulation.
- Drooping eyelid.
- Known allergy to botulinum toxin or human albumin (blood protein).
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 |
|---|---|---|
| Letybo®Also: BoNT/A, botulinum toxin A, Letibotulinumtoxin ADrug is used as part of routine clinical care. This observational study does not assign or modify treatment; it observes outcomes associated with drug use. | Drug | – |
Primary outcome
Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2
Time frame: Week 2
Proportion of subjects achieving a combined responder status, defined as an improvement of at least 1 point from baseline in all 3 treated facial regions at Week 2, as assessed by the investigator using the following validated photo-numeric scales: * Vertical glabellar lines assessed at maximum frowning using the Facial Wrinkle Scale (FWS), a scale ranging from 0 to 3, where higher scores indicate greater wrinkle severity. * Forehead lines assessed at maximum eyebrow elevation using the Croma Dynamic Forehead Line Assessment Scale (CDFLAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity. * Crow's feet assessed at maximum smiling using the Croma Dynamic Crow's Feet Assessment Scale (CDCFAS), a scale ranging from 1 to 5, where higher scores indicate greater wrinkle severity. A subject is considered a responder only if the ≥ 1-point improvement criterion is met for all 3 scales simultaneously.
5 secondary outcomes
Change in vectorial skin displacement at maximum frowning assessed by three-dimensional (3D) surface imaging
Time frame: Week 2, Week 16
Change in vectorial skin displacement during maximum frontalis muscle contraction assessed by three-dimensional (3D) surface imaging
Time frame: Week 2, Week 16
Change in vectorial skin displacement during maximum orbicularis oculi muscle contraction assessed by three-dimensional (3D) surface imaging
Time frame: Week 2, Week 16
Percentage of subjects requiring a touch-up at Week 2
Time frame: Week 2
Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire
Time frame: Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Glabellar Lines
RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar 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.
Nikolaus Duschek, Priv.-Doz., PhD principal investigator
Yuvell
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glabellar Lines and Forehead Lines, run by Yuvell at 1 site in Austria.
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: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2 (time frame: Week 2). 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 29 Jan 2026.