Glabellar LinesPhase 1/2NCT02961673
The Safety and Efficacy Study of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
A Phase 1/2 study testing HU-014 Inj and Botox Inj in people with Glabellar Lines, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glabellar Lines
- What is being tested?
- HU-014 Inj and Botox Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2016to Mar 2017
- Phase
- Phase 1/2
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- 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 has skin disorder including infection and scar on injection site
- 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 Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with Moderate to Severe Glabellar Lines
- Conditions
- Glabellar Lines
- Being tested
- HU-014 Inj, Botox Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU-014 InjBiological
Clostridium botulinum type A
Botox InjBiological
Clostridium botulinum type A
| Study group | Role | What they receive |
|---|---|---|
| HU-014 Inj(Phase 1 and 2) | Experimental | HU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) Receives: Biological: HU-014 Inj |
| Botox Inj(Phase 2) | 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.
Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
Measured: Week 4
Change from Baseline of Glabellar Lines improvement rate(Frown)
Measured: Week 4
Secondary outcomes (5)
Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)
Measured: Week 4, Week 8, Week 12
change from Baseline of Glabellar Lines improvement rate (Frown)
Measured: Week 8, Week 12
change from Baseline of Glabellar Lines improvement rate (Not frown)
Measured: Week4, Week 8, Week 12
Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment
Measured: Week 4, Week 8, Week 12
Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product
Measured: Week 4, Week 8, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startSep 2016
- Primary completionFeb 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glabellar 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huons Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02961673
- Sponsor's protocol ID
- HU-014_P1/2
- Status last verified
- Apr 2018
- First submitted
- 26 Sep 2016
- Last updated
- 12 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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 Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 Versus Botox® in Subject With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT02961673
- Acronym / sponsor ID
- HU-014_P1/2
- Conditions
- Glabellar Lines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Nov 2016 (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.
A Phase I/Ⅱ Clinical Trial to Compare the Safety and Efficacy of HU-014 versus Botox® in Subject with 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 |
|---|---|---|
| HU-014 Inj(Phase 1 and 2) | Experimental | Biological: HU-014 InjHU-014 Inj was given an injection to 5 glabellar lines each 4 U/0.1ml (Total 20 U/0.5ml, IM) |
| Botox Inj(Phase 2) | 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
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- 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 (6 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 has skin disorder including infection and scar on injection site
- 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)
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 |
|---|---|---|
| HU-014 InjClostridium botulinum type A | Biological | HU-014 Inj(Phase 1 and 2) |
| Botox InjClostridium botulinum type A | Biological | Botox Inj(Phase 2) |
Primary outcome
Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1)
Time frame: Week 4
Change from Baseline of Glabellar Lines improvement rate(Frown)
Time frame: Week 4
5 secondary outcomes
Assessment of Columbia Suicide Severity Rating Scale(C-SSRS)
Time frame: Week 4, Week 8, Week 12
change from Baseline of Glabellar Lines improvement rate (Frown)
Time frame: Week 8, Week 12
change from Baseline of Glabellar Lines improvement rate (Not frown)
Time frame: Week4, Week 8, Week 12
Efficacy Outcome Measure (Phase 2) by colleting Subject Satisfaction assessment
Time frame: Week 4, Week 8, Week 12
Assessment of TEAs (Treatment-Emergent Adverse events), ADRs (Adverse Drug Reactions) and SAEs (Serious Adverse Events) after injecting Investigational Product
Time frame: Week 4, Week 8, Week 12
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 12 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Glabellar Lines
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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 1/2 study testing HU-014 Inj and Botox Inj in people with Glabellar 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 6 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of Treatment-Emergent Adverse events (TEAs), Adverse Drug Reactions (ADRs) and Serious Adverse Events (SAEs) after injecting Investigational Product(Phase 1) (time frame: Week 4). The study lists 2 primary outcomes in all. 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.