A Phase 3 interventional study of Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®) in Skin Aging, sponsored by Hugel. Completed at 6 sites in Korea, Republic of. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by Hugel · Phase 3, Interventional, and Treatment
To compare the safety and efficacy of Botulax® with Botox® in the improvement of 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.
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.
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.
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.
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.
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.
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.
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.
Botulinum toxin type A
Drug: Botulinum toxin type A(Botulax®)
Botulinum toxin type A
Drug: Botulinum toxin type A(Botox®)
Single administration, Day 0, 20 units
Single administration, Day 0, 20units
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
Time frame: at 4 weeks post-injection
Safety evaluation in experimental drug treatment group
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 8, 12, 16weeks post injection.
Time frame: 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity
Improvement rate of glabellar lines at rest with investigator's live assessment of severity at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
Improvement rate of glabellar lines at maximum frown with investigator's photo assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
Improvement rate of glabellar lines at rest with investigator's photo assessment at 4, 8, 12, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post inejection
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, 16weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injections
Subject's satisfaction rate
Subject's satisfaction rate of improvement in glabellar lines at 4, 8, 12, 16 weeks post injection
Time frame: 4, 8, 12, 16 weeks post-injection
This study is completed, as verified in Feb 2013. 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