A Phase 3 interventional study of ATGC-100 100U and Botox 100U in Glabellar Frown Lines, sponsored by EuBiologics Co.,Ltd. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by EuBiologics Co.,Ltd · Phase 3, Interventional, and Treatment
Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.
EuBiologics Co.,Ltd is the lead sponsor of 14 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0
Biological: ATGC-100 100U
Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0
Biological: Botox 100U
Clostridium botulinum toxin type A
Clostridium botulinum toxin type A
Proportion of patients with improvement of glabellar lines at maximum frown
Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)
Time frame: 4 weeks post injection compared to baseline
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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EuBiologics Co.,Ltd