The Efficacy and Safety of Protoxin in Subjects With Moderate to Severe Glabellar Lines (NCT06124794) | Clinical Trial Compass
CompletedPhase 3
The Efficacy and Safety of Protoxin in Subjects With Moderate to Severe Glabellar Lines
South Korea155 participantsStarted 2023-12-18
Plain-language summary
This clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT\_BTA\_P3\_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated administration of protoxin in those with moderate or severe brow wrinkles.
Who can participate
Age range
19 Years – 65 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.
Exclusion criteria
. A person who has or is accompanied by the following diseases at the time of screening
. A person with systemic neuromuscular junction disorder that can affect neuromuscular function \[myasthenia gravis (MG), Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis (ALS), etc.\]
. A person with a history of facial paralysis or ptosis
. A person who has skin abnormalities such as infections, skin diseases, scars, etc. at the site to be administered
. A person who has wrinkles to the extent that the glabellar lines cannot be physically flattened, such as when wrinkles are not straightened by hand
. A person who is taking the following drugs
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
Primary Outcome Measure : We will use FWS(Facial wrinkle scale)
Timeframe: 4 weeks post injection compared to baseline
. Within 4 weeks of screening: Drugs with muscle relaxation action, such as muscle relaxants, spectinomycin hydrochloride, aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, anticholinergics, benzodiazepines and similar drugs, and benzamide drugs \[However, for muscle relaxants, benzodiazepines and similar drugs, a person who has stably maintained administration of them from within 4 weeks from the time of screening (the same drug is maintained without changing the usage and dose), and is not expected to change in ingredients, usage, and dose of them during the clinical trial period can be enrolled\]
. A person who has administered aspirin or NSAIDs within 7 days before administration of the investigational product (However, low-dose aspirin (100 mg/day or less) administered for antithrombotic purposes is permitted)