Glabellar Frown LinesPhase 1/2NCT04996810
The Safety and Efficacy Study of PROTOXIN in Subjects With Moderate to Severe Glabellar Lines
A Phase 1/2 study testing PROTOXIN and Botox® in people with Glabellar Frown Lines, run by Protox Inc. at 2 sites in South Korea.
Trial summary
This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the 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 Frown Lines
- What is being tested?
- PROTOXIN and Botox®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 10 Dec 2020to 26 May 2021
- 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
- Men and women aged between 19 to 65 years old
- Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
- Fertile women who have properly agreed to contraception during the clinical trial period
- Subjects who voluntarily sign the informed consent
Who cannot join
- Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
- Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
- Subjects who suffer from muscle weakness or paralysis in the forehead area
- Subjects with infection, skin disorders, or scars at the glabellar region.
- Subjects with noticeable facial asymmetry
- Subjects with allergy or hypersensitivity to the botulinum toxin or their components
Show all 13Show fewer
- Subjects who have taken Anti-Coagulant, Anti-Platelet agent, Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
- Subjects who were injected facial with botulinum toxin within the past 6 months or whose dose exceeds 200 U for the whole body
- Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in the glabellar region
- Subjects who are participating in other clinical trials or have participated in other clinical trials within 4 weeks of the screening date.
- A history of drug or alcohol abuse
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
- Subjects who are not eligible for this study based on the judgment of an investigator
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chung-Ang University Hospital
Seoul
Nowon Eulji Medical Center
Seoul
About this study
Official title: A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines
This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
- Conditions
- Glabellar Frown Lines
- Being tested
- PROTOXIN, Botox®
- Keywords
- Glabellar Lines, Botulinum toxin, Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTOXINBiological
Botulinum toxin Type A
Botox®Biological
Botulinum toxin Type A
| Study group | Role | What they receive |
|---|---|---|
| PROTOXIN (Phase I/II) | Experimental | PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). Receives: Biological: PROTOXIN |
| Botox® (Phase II) | Active comparator | Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). Receives: Biological: Botox® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
Measured: 12 weeks after the injection
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Measured: 4 weeks after the injection
Secondary outcomes (3)
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Measured: 4, 8, 12 weeks after the injection
Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)
Measured: 4, 8, 12 weeks after the injection
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
Measured: 12 weeks after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start10 Dec 2020
- Primary completion2 Apr 2021
- Study completion26 May 2021
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protox Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beomjoon Kim, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996810
- Sponsor's protocol ID
- PT_BTA_P1_20
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Active Comparator, Single-dose, Phase I/II Trial to Evaluate the Safety and Efficacy of Treatment With PROTOXIN as Compared to BOTOX® in Adult Subjects Who Need Improvement of Moderate or Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT04996810
- Acronym / sponsor ID
- PT_BTA_P1_20
- Conditions
- Glabellar Frown Lines
- Keywords
- Glabellar Lines, Botulinum toxin, Botulinum toxin type A
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Protox Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 9 Aug 2021 (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.
This study will be conducted in Phase I/II clinical trials. In Phase I, subjects with moderate to severe glabellar lines are enrolled and those who are judged to be eligible for this study will be injected with the "PROTOXIN" at a total of 20U(4U/0.1mL each) in five sites of the glabellar lines. Safety is assessed after 12 weeks. In Phase II, subjects with moderate to severe glabellar lines are enrolled and will be injected the "PROTOXIN" or the "BOTOX®" at a total of 20U(4U/0.1mL each)in five sites of the glabellar lines. Thereafter, efficacy and safety are assessed by comparing with BOTOX®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROTOXIN (Phase I/II) | Experimental | Biological: PROTOXINPROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). |
| Botox® (Phase II) | Active comparator | Biological: Botox®Botox® will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL). |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 19 to 65 years old
- Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown
- Fertile women who have properly agreed to contraception during the clinical trial period
- Subjects who voluntarily sign the informed consent
Key exclusion criteria (13 listed)
- Subjects who answered 'Yes' any of the C-SSRS questions (only Phase I)
- Subjects with the general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome)
- Subjects who suffer from muscle weakness or paralysis in the forehead area
- Subjects with infection, skin disorders, or scars at the glabellar region.
- Subjects with noticeable facial asymmetry
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 |
|---|---|---|
| PROTOXINBotulinum toxin Type A | Biological | PROTOXIN (Phase I/II) |
| Botox®Botulinum toxin Type A | Biological | Botox® (Phase II) |
Primary outcome
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
Time frame: 12 weeks after the injection
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Time frame: 4 weeks after the injection
3 secondary outcomes
Glabellar line improvement rate confirmed with investigator's assessment (Phase II)
Time frame: 4, 8, 12 weeks after the injection
Glabellar line improvement rate confirmed by subject' satisfaction assessment (Phase II)
Time frame: 4, 8, 12 weeks after the injection
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
Time frame: 12 weeks after the 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 10 Aug 2021.
- 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.
Beomjoon Kim principal investigator
Chung-Ang University Hospital
2 sites 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 PROTOXIN and Botox® in people with Glabellar Frown Lines, run by Protox Inc. at 2 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 13 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 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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?
Evaluate the Number of subjects with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) (time frame: 12 weeks after the injection). 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 10 Aug 2021.