Skin AgingPhase 3NCT01791920
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
A Phase 3 study testing Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®) in people with Skin Aging, run by Hugel at 6 sites in South Korea.
Trial summary
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 6 sitesSouth Korea
- Study dates
- Aug 2011to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 65
- Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
- Patients who voluntarily sign the informed consent
- Patients who can comply with the study procedures and visit schedule
Who cannot join
- Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
- Subjects with skin disorders, scar or infection around glabellar region
- Subjects who are taking Aspirin, NSAIDS or anti-coagulant
- Subjects with facial palsy or eyelid ptosis
- Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
- Subjects with history of drug intoxication, alcohol abuse and/or depressive disorder
Show all 20Show fewer
- Subjects with severe internal diseases (cardiovascular, respiratory, renal disease, liver disorder)
- Subjects who have previously been treated with botulinum toxin within 3 months (Botulinum toxin type A: 3months, type B: 4 months)
- Subject who have administered following drugs within the previous 4 months: Spectinomycin Hydrochloride, Aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, muscle relaxants, anti-cholinergic agents, benzodiazepine and similar drugs, benzamide drugs, Tubocurarine-type muscle relaxants
- Subjects who have possibility to take the drugs listed above
- Subjects who have a plan to receive facial cosmetic procedures including dermal filler, chemical peeling and dermabrasion during study period
- Subjects who have glabellar lines that are unable to be improved with any physical method
- Subjects who have history of hypersensitivity to Botulinum toxin and other agents
- Subjects who are pregnant or breast-feeding
- Subjects who have a plan to be pregnant in 3months, or who are not doing contraceptive
- Subjects who participated in other studies within 30 days or were not passed over 5 times of half life for investigational product
- Subjects who are having trouble with acute disease
- Subjects who have taken any treatment that can affect to glabellar lines and/or any lines around forehead within the previous 6 months
- Subjects who are unable to communicate or follow the instructions
- Subjects who are not eligible for this study based on investigator's judgement
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Chung-Ang University Hopspital
Seoul, Dongjak-gu
Seoul National University Hospital
Seoul, Jongno-Gu
National Medical Center
Seoul, Jung-Gu
Eulji General Hospital
Seoul, Nowon-Gu
The catholic university of Korea, Seoul ST. Mary's Hospital
Seoul, Seocho-Gu
Korea University Anam Hospital
Seoul, Seongbuk-Gu
About this study
Official title: Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
- Conditions
- Skin Aging
- Being tested
- Botulinum toxin type A(Botulax®), Botulinum toxin type A(Botox®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type A(Botulax®)Drug
Single administration, Day 0, 20 units
Botulinum toxin type A(Botox®)Drug
Single administration, Day 0, 20units
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(Botox®) | Active comparator | Botulinum toxin type A Receives: Drug: Botulinum toxin type A(Botulax®) |
| Botulinum toxin type A (Botulax®) | Experimental | Botulinum toxin type A Receives: Drug: Botulinum toxin type A(Botox®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 4 weeks post-injection
Secondary outcomes (7)
Safety evaluation in experimental drug treatment group
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 4, 8, 12, 16 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791920
- Sponsor's protocol ID
- HG-11-01
- Status last verified
- Feb 2013
- First submitted
- 13 Feb 2013
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blinded, Randomized, Active Control Comparative, Multicenter-designed, Phase III Clinical Trial to Evaluate the Safety and Efficacy for Improvement of Glabellar Lines of "Botulax®" Compared to Botox Inj. in Patients With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT01791920
- Acronym / sponsor ID
- HG-11-01
- Conditions
- Skin Aging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A(Botox®) | Active comparator | Drug: Botulinum toxin type A(Botulax®)Botulinum toxin type A |
| Botulinum toxin type A (Botulax®) | Experimental | Drug: Botulinum toxin type A(Botox®)Botulinum toxin type A |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 18 and 65
- Patients attaining grade 2 or 3 in the investigator's rating of glabellar lines severity at maximum frown
- Patients who voluntarily sign the informed consent
- Patients who can comply with the study procedures and visit schedule
Key exclusion criteria (20 listed)
- Subjects who had facial plastic surgery (tissue augmentation, brow lift, and dermal resurfacing)treatment within 6 months. Those who had peeling or laser therapy
- Subjects with skin disorders, scar or infection around glabellar region
- Subjects who are taking Aspirin, NSAIDS or anti-coagulant
- Subjects with facial palsy or eyelid ptosis
- Subjects who diagnosed as neuromuscular junction disorder (e.g., myasthenia gravis, Lambert-Eaton Syndrome)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type A(Botulax®)Single administration, Day 0, 20 units | Drug | Botulinum toxin type A(Botox®) |
| Botulinum toxin type A(Botox®)Single administration, Day 0, 20units | Drug | Botulinum toxin type A (Botulax®) |
Primary outcome
Responder rate of improvement in glabellar lines with Physician's rating of line severity
Time frame: at 4 weeks post-injection
Improvement rate of glabellar lines at maximum frown with Physician's rating of lines severity at 4weeks post injection.
7 secondary outcomes
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
Time frame: 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's live assessment of severity
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at maximum frown with investigator's photo assessment
Time frame: 4, 8, 12, 16 weeks post-injection
Responder rate of improvement in glabellar lines at rest with investigator's photo assessment
Time frame: 4, 8, 12, 16 weeks post inejection
Responder rate of improvement in glabellar lines with Subject's improvement assessment
Time frame: 4, 8, 12, 16 weeks post-injections
Subject's satisfaction rate
Time frame: 4, 8, 12, 16 weeks post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A(Botulax®) and Botulinum toxin type A(Botox®) in people with Skin Aging, run by Hugel at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate of improvement in glabellar lines with Physician's rating of line severity (time frame: at 4 weeks post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.