Crow's Feet LinesPhase 3NCT04081402
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
A Phase 3 study testing HU-014 and Botox Inj in people with Crow's Feet Lines, run by Huons Co., Ltd. at 1 site in South Korea.
Trial summary
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Crow's Feet Lines
- What is being tested?
- HU-014 and Botox Inj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2018to Feb 2020
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
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 within 48 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
A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
- Conditions
- Crow's Feet Lines
- Being tested
- HU-014, Botox Inj
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HU-014Biological
Hutox Inj(Clostridium botulinum type A)
Botox InjBiological
Botox Inj(Clostridium botulinum type A)
| Study group | Role | What they receive |
|---|---|---|
| HU-014 Inj | Experimental | Not described Receives: Biological: HU-014 |
| Botox Inj | Active comparator | Not described Receives: Biological: Botox Inj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
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 posted9 Sep 2019
- Study start1 Nov 2018
- Primary completionNov 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's Feet 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
- 290 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
- NCT04081402
- Sponsor's protocol ID
- HU-014_P1/3_CFL
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 9 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet Lines
- ClinicalTrials.gov ID
- NCT04081402
- Acronym / sponsor ID
- HU-014_P1/3_CFL
- Conditions
- Crow's Feet Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Huons Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 9 Sep 2019 (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 1/3 Clinical Trial to Evaluate the Safety and Efficacy of HUTOX Compared to Botox® in Subjects With Moderate to Severe Crow's Feet 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 |
|---|---|---|
| HU-014 Inj | Experimental | Biological: HU-014 |
| Botox Inj | Active comparator | Biological: Botox Inj |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
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 within 48 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-014Hutox Inj(Clostridium botulinum type A) | Biological | HU-014 Inj |
| Botox InjBotox Inj(Clostridium botulinum type A) | Biological | Botox Inj |
Primary outcome
Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4]
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Individual participant dataSharing planned: No
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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.
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 HU-014 and Botox Inj in people with Crow's Feet 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: status not confirmed, as of the sponsor's last update on 9 Sep 2019. 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?
Contact Jungmin Yu, Researcher (070-7492-5100, jungmin-yu@huons.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of Crow's feet Lines improvement rate [Time Frame: Week 4] (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 9 Sep 2019.