A Phase 1 interventional study of Botulinum Toxin Type A Injection [Botox] and Botulinum toxin type A injection [HG-102] in Glabellar Lines, sponsored by Hugel. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by Hugel · Phase 1, Interventional, and Treatment
To compare the safety and efficacy of "HG-102" with Botox® in the improvement of moderate to severe glabellar lines.
Double-blinded, Randomized, Active control, Single center-designed, Phase I clinical trial to evaluate the safety and efficacy for improvement of Glabellar Lines of "HG-102" compared to Botox® in subjects with moderate to severe Glabellar Lines
Hugel is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Botulinum toxin type A(Botox®) 100 Unit
Drug: Botulinum Toxin Type A Injection [Botox]
Botulinum toxin type A(HG-102) 100 Unit
Drug: Botulinum toxin type A injection [HG-102]
Single administration, Day 0, 20 units
Also known as: Botox®
Single administration, Day 0, 20 units
Also known as: HG-102
Adverse event and adverse drug reaction incidence rates
Time frame: Baseline to week 16
Clinically-relevant changes in vital signs, physical exam, and laboratory testing assessed by medical personnel
Time frame: 16 weeks (during the clinical trial)
Responder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating line severity at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at rest with Physician's rating line severity at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Changes in grade by physician's rating line severity for glabellar lines
Changes in grade(range from 0(None) to 3(Severe)) by physician's rating line severity for glabellar lines at each visit compared to baseline
Time frame: Baseline to week 4, 8, 12, 16
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Improvement rate of glabellar lines with Subject's improvement assessment at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
Subject's satisfaction rate
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
Time frame: Baseline to week 4, 8, 12, 16
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS)
The severity of pain evaluated by the subject's Simple Descriptive Scale (SDS) at immediately and about 30 minutes post injection (severity range is from 1(no pain) to 5(unbearable pain))
Time frame: Baseline
Ran from Jun 2021 to primary completion in Sep 2021, 2 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Hugel