Glabellar Frown LinesPhase 3NCT06124794
The Efficacy and Safety of Protoxin in Subjects With Moderate to Severe Glabellar Lines
A Phase 3 study testing PROTOXIN in people with Glabellar Frown Lines, run by Protox Inc. at 3 sites in South Korea.
Trial summary
This clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 18 Dec 2023to 14 Jun 2024
- 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
- PT_BTA_P3_21 (clinical trial plan number) Test subjects who participated in clinical trials and completed follow-up observation up to 16 weeks after administration of clinical trial drugs
- 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
- A person who has or is accompanied by the following diseases at the time of screening
- A person with systemic neuromuscular junction disorder that can affect neuromuscular function [myasthenia gravis (MG), Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis (ALS), etc.]
- A person with a history of facial paralysis or ptosis
- A person who has skin abnormalities such as infections, skin diseases, scars, etc. at the site to be administered
- A person who has wrinkles to the extent that the glabellar lines cannot be physically flattened, such as when wrinkles are not straightened by hand
- A person who is taking the following drugs
Show all 28Show fewer
- Within 4 weeks of screening: Drugs with muscle relaxation action, such as muscle relaxants, spectinomycin hydrochloride, aminoglycoside antibiotics, polypeptide antibiotics, tetracycline antibiotics, lincomycin antibiotics, anticholinergics, benzodiazepines and similar drugs, and benzamide drugs [However, for muscle relaxants, benzodiazepines and similar drugs, a person who has stably maintained administration of them from within 4 weeks from the time of screening (the same drug is maintained without changing the usage and dose), and is not expected to change in ingredients, usage, and dose of them during the clinical trial period can be enrolled]
- A person who has administered aspirin or NSAIDs within 7 days before administration of the investigational product (However, low-dose aspirin (100 mg/day or less) administered for antithrombotic purposes is permitted)
- A person who has had procedure/surgery that may affect the wrinkles around the glabellar or forehead during the following period
- Within 48 weeks of screening: Tissue augmentation
- Within 24 weeks of screening: A person who has undergone facial plastic surgery including glabellar lines such as brow lift, dermal resurfacing, or peeling, etc.
- A person with a history of surgery or treatment around the orbit (except for double eyelid surgery, epicanthal fold (Mongolian fold) correction)
- A person who is planning to undergo facial cosmetic procedures such as dermal filler, photorejuvenation, chemical peeling, and dermabrasionduring the clinical trial period
- PT_BTA_P3_21 (Clinical Trial Plan Number) A person who received similar drugs for clinical trials such as botulinum toxin A and B after visiting the end of phase 3 clinical trials)
- A person who is expected to administer botulinum toxin formulations other than this investigational product during the clinical trial period
- A person with a history of hypersensitivity or allergy to the components of the investigational product (botulinum toxin formulations and serum albumin, etc.)
- A person with a history of alcohol or drug addiction
- A person who, in the investigator's judgment, may affect clinical trial participation or objective efficacy evaluation results, due to anxiety disorders or other significant psychiatric disorders (e.g., severe depression)
- Women and men of childbearing potential who plan to become pregnant or do not intend to use appropriate contraceptive methods* during the clinical trial period
- Appropriate contraceptive methods
- Using either hormonal contraceptives (subcutaneous implants, injections, oral contraceptives, etc.) or spermicide in combination with physical barrier methods (condoms, contraceptive diaphragms, vaginal sponges, cervical caps)
- Implantation of an intrauterine device or intrauterine system: A copper loop, hormone-containing intrauterine system
- Both men (condoms) and women (contraceptive diaphragms, vaginal sponges or cervical caps) use physical barrier methods together
- Surgical sterilization procedure/surgery: Bilateral tubal ligation, vasectomy, etc.
- Pregnant or lactating women
- A person with serious comorbidities (e.g., malignant tumors, immunodeficiency (decreased immune function), renal disease, liver disease, heart disease, respiratory disease, etc.) or acute diseases that are unsuitable for participation in the clinical trial as judged by the investigator
- A person who participated in other clinical trials/clinical device trials within 30 days prior to screening and received administration/treatment of investigational products/devices, or a person for whom the longer period has not passed between the above period and 5 times the half-life of the investigational product in the clinical trial in which they participated
- Others who are judged inappropriate to participate in this clinical trial by the investigator
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
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, Single Group, Open, Extension Study of Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin in Subjects With Moderate to Severe Glabellar Lines
This clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated administration of protoxin in those with moderate or severe brow wrinkles.
- Conditions
- Glabellar Frown Lines
- Being tested
- PROTOXIN
- 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
Clostridium botulinum toxin type A
| Study group | Role | What they receive |
|---|---|---|
| PROTOXIN 100U (Clostridium botulinum toxin type A) | Experimental | PROTOXIN will be injected to 5 glabellar lines (Each 4U/0.1mL, Total 20U/0.5mL) Receives: Biological: PROTOXIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), the improvement rate of brow wrinkles at 4 weeks after the administration of protoxin week and the improvement rate at the time of raising at 4 weeks after the administration of protoxin week in this extended clinical trial are compared and evaluated.
Measured: 4 weeks post injection compared to baseline
Secondary outcomes (6)
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), the improvement rate of brow wrinkles at 8, 12, and 16 weeks after the administration of protoxin week is compared with the improvement rate of brow wrinkles at 8, 12, and 16 weeks after the administration of protoxin week in this extended clinical trial.
Measured: Week 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), we compare the improvement rate of normal brow wrinkles according to the tester's field evaluation at 4, 8, 12, and 16 weeks after the protoxin injection with the usual brow wrinkles according to the tester's field evaluation at 4, 8, 12, and 16 weeks after the protoxin injection in this extended clinical trial.
Measured: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), the improvement rate of normal brow wrinkles is compared with the improvement rate of normal brow wrinkles at 4, 8, 12, and 16 weeks after the administration of protoxin in this extended clinical trial.
Measured: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), the rate of improvement of brow wrinkles at 4, 8, 12, and 16 weeks after Botox week administration and the rate of improvement of brow wrinkles at 4, 8, 12, and 16 weeks after protoxin week administration in this extended clinical trial are compared and evaluated.
Measured: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In the Phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), the proportion of test subjects satisfied in the satisfaction assessment of test subjects at 4, 8, 12, and 16 weeks after the administration of protoxin in this extended clinical trial is compared with the proportion of test subjects satisfied in the satisfaction assessment of test subjects at 4, 8, 12, and 16 weeks after the administration of protoxin.
Measured: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
In Phase 3 of PT_B, comparing the proportion of subjects satisfied in the satisfaction assessment of subjects at week 4, 8, 12, and 16 after the main administration of PT_P3_21 (clinical trial plan number), and the proportion of subjects satisfied in the satisfaction assessment of subjects at week 4, 8, 12, and 16 after the main administration of protoxin, in this extended clinical trial.
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 posted9 Nov 2023
- Study start18 Dec 2023
- Primary completion26 Feb 2024
- Study completion14 Jun 2024
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
- Not applicable
- Intervention model
- Single group
- Model description
- A Multicenter, Single group, Open, Extension Study of Phase III Clinical Trial
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Protox Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beomjoon Kim, PI, Principal investigator, Chung-Ang University HospitalYangone Lee, CI, Principal investigator, Konkuk University Medical CenterJonghoon Lee, PI, Principal investigator, Nown Eulji Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124794
- Sponsor's protocol ID
- PT_BTA_P3_21_EXT
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 21 Jun 2024
- 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 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single Group, Open, Extension Study of Phase III Clinical Trial to Compare the Efficacy and Safety of Protoxin in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT06124794
- Acronym / sponsor ID
- PT_BTA_P3_21_EXT
- Conditions
- Glabellar Frown Lines
- Keywords
- Glabellar Lines, Botulinum toxin, Botulinum toxin type A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Protox Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 26 Feb 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 9 Nov 2023 (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 clinical trial is an extended clinical trial for test subjects who participated in the phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number) and completed follow-up observation up to 16 weeks after administration of clinical trial drugs, and evaluates the effectiveness and safety of repeated administration of protoxin in those with moderate or severe brow wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Multicenter, Single group, Open, Extension Study of Phase III Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| PROTOXIN 100U (Clostridium botulinum toxin type A) | Experimental | Biological: PROTOXINPROTOXIN 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 (5 listed)
- PT_BTA_P3_21 (clinical trial plan number) Test subjects who participated in clinical trials and completed follow-up observation up to 16 weeks after administration of clinical trial drugs
- 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 (28 listed)
- A person who has or is accompanied by the following diseases at the time of screening
- A person who has wrinkles to the extent that the glabellar lines cannot be physically flattened, such as when wrinkles are not straightened by hand
- A person who is taking the following drugs
- A person who has had procedure/surgery that may affect the wrinkles around the glabellar or forehead during the following period
- A person with a history of surgery or treatment around the orbit (except for double eyelid surgery, epicanthal fold (Mongolian fold) correction)
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 |
|---|---|---|
| PROTOXINClostridium botulinum toxin type A | Biological | PROTOXIN 100U (Clostridium botulinum toxin type A) |
Primary outcome
Primary Outcome Measure : We will use FWS(Facial wrinkle scale)
Time frame: 4 weeks post injection compared to baseline
In the Phase 3 clinical trial of PT_BTA_P3_21 (clinical trial plan number), the improvement rate of brow wrinkles at 4 weeks after the administration of protoxin week and the improvement rate at the time of raising at 4 weeks after the administration of protoxin week in this extended clinical trial are compared and evaluated.
6 secondary outcomes
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
Time frame: Week 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
Time frame: Week 4, 8, 12, 16
Secondary Outcome Measures : We will use FWS(Facial wrinkle scale)
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 21 Jun 2024.
- 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, PI principal investigator
Chung-Ang University Hospital
Yangone Lee, CI principal investigator
Konkuk University Medical Center
Jonghoon Lee, PI principal investigator
Nown Eulji Medical Center
3 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 in people with Glabellar Frown Lines, run by Protox Inc. at 3 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 5 inclusion and 28 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 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Primary Outcome Measure : We will use FWS(Facial wrinkle scale) (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?
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 21 Jun 2024.