Glabellar Frown LinesPhase 3NCT05364580
The Efficacy and Safety Study of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
A Phase 3 study testing PROTOXIN and Botox® in people with Glabellar Frown Lines, run by Protox Inc. at 5 sites in South Korea.
Trial summary
This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, 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
- 269 participants
- Where
- 5 sitesSouth Korea
- Study dates
- 6 Mar 2023to 6 Oct 2023
- 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
- Men and women aged between 19 to 65 years old
- Subjects attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Those who understand and comply with clinical trial procedures and visit schedules
- Subjects who voluntarily decides to participate and signs the consent form after hearing the explanation of this clinical trial.
Who cannot join
- Those with or accompanied by the following diseases at the time of screening
- Subjects with Neuromuscular Junction Disorder that may affect neuromuscular action
- Subjects with previous history of weakness or paralysis in the forehead area
- Subjects with infection, skin disorders, or scars at the glabellar region
- Subjects with wrinkles that physically prevent wrinkles from spreading, such as when wrinkles are not spread out by hand
- Subjects who is administering a drug with muscle relaxation within four weeks of screening.
Show all 19Show fewer
- Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
- Subjects with surgical history who may affect wrinkles around the forehead or glabellar region
- Subjects who have planned facial cosmetic procedure during the clinical trial
- Subjects who have been administered similar drugs within 12 weeks (Botulinum toxin type A) or within 16 weeks (Botulinum toxin type B) before screening
- Subjects who are expected to administer botulinum toxin preparations other than Investigational product during the clinical trial period
- Subjects with allergy or hypersensitivity to the botulinum toxin or their components
- A history of drug or alcohol abuse
- Anxiety disorders or other significant mental disorders based on the judgment of an investigator
- Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception
- Pregnant or lactating women
- Subjects with severe comorbidities or acute diseases that does not suitable for participation in clinical trials
- Those who participated in other clinical trials/clinical medical device trials within 30 days prior to screening and who received Investigational product/medical devices/procedures, or those who had less than 5 times the half-life of the Investigational product
- Subjects who are not eligible for this study based on the judgment of an investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Pusan National University Hospital
Pusan, Seo-gu
Kyung Hee University Hospital
Seoul, Dongdaemun-gu
Chung-Ang University Hospital
Seoul, Gwangjin-gu
Konkuk University Hospital
Seoul, Gwangjin-gu
Nowon Eulji Medical Center
Seoul, Nowon-gu
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
This study will be conducted in Phase Ⅲ clinical trials. In Phase Ⅲ, 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. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.
- 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 Ⅲ) | Experimental | PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL) Receives: Biological: PROTOXIN |
| Botox® (Phase Ⅲ) | 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.
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: 4 weeks post injection compared to baseline
Secondary outcomes (7)
Investigator-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: Week 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: Week 4, 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
Measured: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Participant evaluate the level of satisfaction by Patient Satisfaction(PS) 7-grade score(1 to 7) where 1 = very dissatisfied and 7 = very satisfied
Measured: Week 4, 8, 12, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start6 Mar 2023
- Primary completion20 Jun 2023
- Study completion6 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 269 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protox Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Beomjoon, Principal investigator, Chung-Ang University Hospital, Chung-Ang University College of MedicineLee Yangwon, Principal investigator, Konkuk University Medical CenterKim Moonbeom, Principal investigator, Pusan National University HospitalLee Jonghoon, Principal investigator, Nown Eulji Medical Center, Eulji UniversityShin Minkyung, Principal investigator, Kyunghee University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364580
- Sponsor's protocol ID
- PT_BTA_P3_21
- Status last verified
- Mar 2023
- First submitted
- 19 Apr 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Son HS, Shin MK, Lee JH, Kim MB, Yoo KH, Choi SY, Han HS, Seok J, Kim BJ, Lee YW. Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study. Ann Dermatol. 2026 Feb;38(1):33-41. doi: 10.5021/ad.25.124.
PubMed 41607140
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin Versus Botox® in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05364580
- Acronym / sponsor ID
- PT_BTA_P3_21
- Conditions
- Glabellar Frown Lines
- Keywords
- Glabellar Lines, Botulinum toxin, Botulinum toxin type A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 269 participants (actual)
- Lead sponsor
- Protox Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 6 May 2022 (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 Ⅲ clinical trials. In Phase Ⅲ, 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. The investigational product is administered once, maintaining double-blind for a total of 16 weeks of observation. Thereafter, efficacy and safety are assessed by comparing with BOTOX® after regular visits conducted at 4,8,12 and 16 weeks.
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 Ⅲ) | Experimental | Biological: PROTOXINPROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL) |
| Botox® (Phase Ⅲ) | 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 glabella lines at maximum frown
- Those who understand and comply with clinical trial procedures and visit schedules
- Subjects who voluntarily decides to participate and signs the consent form after hearing the explanation of this clinical trial.
Key exclusion criteria (19 listed)
- Those with or accompanied by the following diseases at the time of screening
- Subjects with wrinkles that physically prevent wrinkles from spreading, such as when wrinkles are not spread out by hand
- Subjects who is administering a drug with muscle relaxation within four weeks of screening.
- Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of the investigational drug
- Subjects with surgical history who may affect wrinkles around the forehead or glabellar region
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 Ⅲ) |
| Botox®Botulinum toxin Type A | Biological | Botox® (Phase Ⅲ) |
Primary outcome
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4
Time frame: 4 weeks post injection compared to baseline
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe
7 secondary outcomes
Investigator-rated improvement rate of glabellar lines at maximum frown
Time frame: Week 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
Time frame: Week 4, 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at frown
Time frame: Week 4, 8, 12, 16
Independent photo evaluator-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Time frame: Week 4, 8, 12, 16
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 18 Nov 2023.
- Derived from this study: PubMed 41607140Son HS, Shin MK, Lee JH, Kim MB, Yoo KH, Choi SY, Han HS, Seok J, Kim BJ, Lee YW. Efficacy and Safety of Novel Botulinum Toxin Type A (Protoxin) in the Treatment of Moderate to Severe Glabellar Lines: A Multicenter, Randomized, Double-Blind, Active-Controlled Phase III Study. Ann Dermatol. 2026 Feb;38(1):33-41. doi: 10.5021/ad.25.124.
- 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.
Kim Beomjoon principal investigator
Chung-Ang University Hospital, Chung-Ang University College of Medicine
Lee Yangwon principal investigator
Konkuk University Medical Center
Kim Moonbeom principal investigator
Pusan National University Hospital
5 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 PROTOXIN and Botox® in people with Glabellar Frown Lines, run by Protox Inc. at 5 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 19 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Proportion of subjects achieving at least a 2-grade improvement from baseline on the facial wrinkle scale of GL at maximum frown at Week 4 (time frame: 4 weeks post injection compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364580, which also lists 1 linked publication.
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 18 Nov 2023.