A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A

NCT07374965 | Completed

• 1 other identifier: YUV-NIS-001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Week 2

Secondary Outcomes (5)

• Change in vectorial skin displacement at maximum frowning assessed by three-dimensional (3D) surface imaging

  Week 2, Week 16

• Change in vectorial skin displacement during maximum frontalis muscle contraction assessed by three-dimensional (3D) surface imaging

  Week 2, Week 16

• Change in vectorial skin displacement during maximum orbicularis oculi muscle contraction assessed by three-dimensional (3D) surface imaging

  Week 2, Week 16

• Percentage of subjects requiring a touch-up at Week 2

  Week 2

• Patient satisfaction with treatment assessed using a clinic-internal patient satisfaction questionnaire

  Week 16

Interventions

Letybo® DRUG

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.

Also known as: BoNT/A, botulinum toxin A, Letibotulinumtoxin A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the clinic for such a treatment as part of routine clinical practice.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Croma-Pharma GmbH: collaborator
• Yuvell: lead

Study Sites (1)

YUVELL

Vienna, Vienna, 1010, Austria

Location

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Nikolaus Duschek, Priv.-Doz., PhD

  Yuvell

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2026
• First Posted: January 29, 2026
• Study Start: January 29, 2024
• Primary Completion: May 16, 2024
• Study Completion: September 9, 2024
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

AU (1)