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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT02568150
Eligibility Criteria:
Inclusion Criteria
1. Males and Females who are at least 20 years old and not older than 65 years old
2. Subjects who have a least 2 points (moderate) of glabellar lines at maximum frown to the maximum confirmed with investigator's line assessment severity.
3. Subjects who can comply well with clinical study procedures and visit schedules
4. Subjects who voluntarily signed the Informed Consent Form
Exclusion Criteria
1. Subjects with diseases that can affect neuromuscular functioning such as oderate muscle weakness, Eaton-Lambert Syndrome, Amyotrophic side sclerosis, motor neuropathy, etc.
2. Subjects who took aminoglycoside antibiotics, curare-like agents or drugs that inhibit neuromuscular functioning (including muscle relaxants, anticholinergic type, benzodiazepine type, benzamide type, tetracycline type, or lincomycin type of antibiotics) within 4 weeks prior to screening
3. Subjects with skin abnormality near the injection site such as infection, skin disease, or scar
4. In case where subject underwent other procedures that may affect the glabellar lines or brow area within 6 months prior to screening
5. Subjects who received botulinum Type A toxin products within 8 months prior to screening or received botulinum Type B products within 8 months prior to screening
6. Subjects whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands.
7. Subjects with facial paralysis or history of blepharoptosis
8. Subjects who are pregnant, lactating or who plan to be pregnant during the clinical period or females of child bearing years who do not use available contraceptive methods (subjects of child bearing years must be negative from a pregnancy test prior to injection.)
9. Subjects allergic to or sensitive to the Investigational Product or applicable ingredients
10. Subjects taking aspirin, NSAIDs or anticoagulant
11. Subjects who have participated in another clinical study within 30 days prior to screening or patient who participated in a clinical study and the period of 5 times the Investigational Product's half life has not passed
12. Other subjects who are deemed not to be appropriate for this clinical study in the discretion of investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT02568150
Study Brief:
Protocol Section:
NCT02568150