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

Yuvell

Status: Completed

Conditions: Glabellar Lines; Crow's Feet; Canthal Lines; Forehead Lines

Treatments: Drug: Letybo®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07374965

YUV-NIS-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.