Glabellar Frown LinesPhase 3NCT03440671
The Safety and Efficacy Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
A Phase 3 study testing Hutox Inj and Botox Inj in people with Glabellar Frown Lines, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Hutox Inj and Botox Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2017to 30 Dec 2018
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely
Who cannot join
- Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
- Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc
- Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
- Any condition that, in the view of the investigator, would interfere with study participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines
- Conditions
- Glabellar Frown Lines
- Being tested
- Hutox Inj, Botox Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hutox InjBiological
Hutox Inj(Clostridium botulinum type A)
Botox InjBiological
Botox Inj(Clostridium botulinum type A)
| Study group | Role | What they receive |
|---|---|---|
| Hutox Inj | Experimental | Hutox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) Receives: Biological: Hutox Inj |
| Botox Inj | Active comparator | Botox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) Receives: Biological: Botox Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
FWS(Facial Wrinkle Severity) Improvement at glabellar line
Change from Baseline of Glabellar Lines improvement rate(Frown)
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start30 Nov 2017
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar Frown LinesStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03440671
- Sponsor's protocol ID
- HU-014_P3
- Status last verified
- Apr 2018
- First submitted
- 11 Jan 2018
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety Study of Hutox Versus Botox® in Subject With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT03440671
- Acronym / sponsor ID
- HU-014_P3
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Dec 2018 (estimated)
- First posted
- 22 Feb 2018 (actual)
- 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.
A Phase Ⅲ Clinical Trial to Compare the Safety and Efficacy of Hutox versus Botox® in Subject with Moderate to Severe Glabellar Lines
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hutox Inj | Experimental | Biological: Hutox InjHutox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) |
| Botox Inj | Active comparator | Biological: Botox InjBotox Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Facial Wrinkle Scale (FWS) score > 2 when Subject knits brow extremely
Key exclusion criteria (5 listed)
- Volunteer who has history of any diseases following. (myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis etc.)
- From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
- Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc
- Subject who takes a medication including anticoagulant, antithrombotic drug except low dose aspirin (below 325 mg/day)
- Any condition that, in the view of the investigator, would interfere with study participation
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 |
|---|---|---|
| Hutox InjHutox Inj(Clostridium botulinum type A) | Biological | Hutox Inj |
| Botox InjBotox Inj(Clostridium botulinum type A) | Biological | Botox Inj |
Primary outcome
FWS(Facial Wrinkle Severity) Improvement at glabellar line
Time frame: 4 Weeks
Change from Baseline of Glabellar Lines improvement rate(Frown)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hutox Inj and Botox Inj in people with Glabellar Frown Lines, run by Huons Co., Ltd. at 1 site 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
FWS(Facial Wrinkle Severity) Improvement at glabellar line (time frame: 4 Weeks). 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 12 Apr 2018.