A Phase 3 interventional study of Botulinum Toxin Type A Injection [HG102] and Botulinum Toxin Type A Injection [Botox] in Glabellar Lines, sponsored by Hugel. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-16.
Sponsored by Hugel · Phase 3, Interventional, and Treatment
To evaluate the efficacy and safety of HG102 for moderate to severe Glabellar Lines, non-inferiority compared to Botox® was confirmed and safety was evaluated.
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.
Subjects that fit all of the criteria below were selected for this clinical trial.
Exclusion Criteria:
Subjects that fit any of the criteria below were excluded from this clinical trial.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Drug: Botulinum Toxin Type A Injection [HG102]
Drug: Botulinum Toxin Type A Injection [Botox]
Single administration, Day 0, 20 units
Also known as: HG102
Single administration, Day 0, 20 units
Also known as: Botox®
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 weeks post injection
Time frame: Baseline to week 4
Responder rate of improvement in glabellar lines with Physician's rating line severity
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 8, 12, 16 weeks post injection
Time frame: Baseline to week 8, 12, 16
Responder rate of improvement in glabellar lines with investigator's photo assessment
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
Independent photo evaluator-rated improvement rate of glabellar lines at rest
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
Participant-rated satisfaction after treatment
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
Plan to share: No
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Studies of the drug tested here: Botulinum toxin type A
Hugel