A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper… (NCT07374965) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Non-Interventional, Single-Centre Study Assessing the Efficacy of a Holistic Upper Face Treatment With Botulinum Neurotoxin A
Austria20 participantsStarted 2024-01-29
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of subjects with a combined ≥ 1-point improvement in glabellar lines, forehead lines, and crow's feet severity at Week 2