Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:34 PM
Ignite Modification Date:
2025-12-24 @ 5:34 PM
NCT ID:
NCT05531968
Eligibility Criteria:
Inclusion Criteria:
1. Men and women aged between 19 and 65
2. Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
3. Patients who fully understand the clinical trial and voluntarily sign the informed consent
Exclusion Criteria:
1. Patients with neuromuscular junction disorders (e.g., myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis\[ALS\], etc.)
2. Patients with facial palsy or blepharoptosis
3. Patients who have marked facial asymmetry
4. Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
5. Patients who have received the medications that cause relaxation of muscles all over the body within 4 weeks prior to screening
* Muscle Relaxants (e.g., Tubocurarine chloride, Dantrolene sodium, Baclofen, etc.)
* Spectinomycin hydrochloride
* Aminoglycoside antibiotics (e.g., Gentamicin sulfate, Neomycin sulfate, etc.)
* Polypeptide antibiotics (e.g., Polymyxin B sulfate, etc.)
* Tetracycline antibiotics
* Lincosamide antibiotics
* Aanticholinergic agent (e.g., Butylscopolamine bromide, Trihexyphenidyl hydrochloride, etc.)
* Benzodiazepines (e.g., Diazepam, Etizolam, etc.)
* Other medications that cause relaxation of muscles all over the body
6. Patients who have received anticoagulant, antiplatelet agent or NSAIDs within 7 days before the first dose (Allow use of low-dose Aspirin\[325 mg/day or less\] for the antithrombotic therapy)
7. Patients with skin disorders, infection or scars at the injection site
8. Patients who have received other procedures which may affect glabellar and forehead lines within 12 months prior to screening
* Permanent soft tissue augmentation (e.g., Permanent filler, etc.)
* Face lifting (e.g., Forehead/Browlift, Thread lifting, etc.)
* Implant and Fat grafting
9. Patients with the history of treatment of glabellar part(including forehead) which may affect the treatment results
* Hyaluronic Acid/Collagen fillers, Dermal resurfacing, Chemical Peeling, dermabrasion and Dermal Photorejuvenation within 6 months
* Dermer Filler and Nonpermanent soft tissue filler within 12 months
10. Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
11. Patients who have a history of injecting drugs similar to the investigational drugs within 6 months prior to selection or are foreseen to use Botulinum Toxin A type or Botulinum Toxin B type during the study period
12. Patients who have received Retinoids (e.g., isotretinoin, alitretinoin, etc.)
* Systemic agents: within 6 months prior to screening
* Topical agents: within 3 months prior to screening
13. Patients with the history of alcohol or drug addiction
14. Patients who have anxiety or mental disorder (e.g., depression) which may affect patient participation or objective efficacy assessment results based on the judgment of an investigator
15. Fertile women and men who have a plan on being pregnant during the study or are not willing to use appropriate contraception
16. Pregnant or lactating women
17. Patients with allergy or hypersensitivity to the investigational drugs or their components
18. Patients who have a disorder associated with malignant tumor, immunodeficiency(weak immune system), kidney disease, liver disease lung disease or etc., which is unsuitable for participation of the study based on the judgment of an investigator
19. Patients who have participated in other clinical trials and were received or applied with other investigational products or investigational device within 30 days prior to screening
20. Patients whom the investigator judges to be unsuitable to participate
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT05531968
Study Brief:
Protocol Section:
NCT05531968