Glabellar Frown LinesPhase 3NCT05623410
Study to Compare the Efficacy and Safety of ATGC-110 (Botulinum Toxin) With Xeomin® for the Treatment of Moderate to Severe Glabellar Frown Lines
A Phase 3 study testing ATGC-110 and Xeomin® in people with Glabellar Frown Lines, run by ATGC Co., Ltd. at 1 site in South Korea.
Trial summary
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown 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?
- ATGC-110 and Xeomin®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2022to 10 Jun 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
- Male and female subjects aged between 19 to 65 years
- Subjects assigned a glabellar line severity grade of 2 or greater (moderate) at maximum frown assessed by the Investigator
- Subjects who provide written consent to voluntarily participate in the study after receiving and understanding a detailed explanation of the study
Who cannot join
- Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy etc.)
- Subjects with the history of eyelid paralysis or ptosis
- Subjects with significant facial asymmetry
- Subjects whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
- Infection, dermatological condition or scar at the treatment injection sites
- Subjects currently suffering acute diseases
Show all 23Show fewer
- Subjects with the history of excessive alcohol consumption or drug addiction
- Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion
- Subjects with concomitant illnesses that make them unsuitable for participation in the study by the Investigator such as malignant tumors, immunodeficiency (immune deficiency), kidney disease, liver disease, or lung disease
- Subjects with the history of treatment of the glabellar region (including the forehead) such as face lifting, permanent implants, or fillers
- Subjects who have received other procedures that may affect the assessment of the glabellar or forehead lines during the following periods; Within 6 months of screening: main ingredient hyaluronic acid skin filler, dermal resurfacing, chemical/mechanical skin peeling, skin peeling, Dermal photorejuvenation; Within 12 months of screening: Dermal fillers other than the main ingredient hyaluronic acid, nonpermanent soft tissue fillers
- Subjects who have received medication that inhibits neuromuscular function within the 4 weeks prior to screening such as muscle relaxants, anticholinergics, benzodiazepines and similar drugs, benzamides, tetracycline antibiotics, lincomycin antibiotics, and aminoglycoside antibiotics
- Subjects who have taken retinoid drugs (Isotretinoin, Alitretinoin, etc.) during the following period; Oral and systemic use: within 6 months of screening Topical applied on the face: within 3 months of screening
- Subjects who have received aspirin or NSAIDs within 7 days prior to administration of the IP (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed).
- Subjects taking anticoagulants or antiplatelet agents (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed)
- Subjects who are allergic or sensitive to the IP or its components
- Subjects who have received botulinum toxin preparations within 6 months from the time of screening
- Female subjects of childbearing age who do not agree to practice contraception using medically allowed contraceptive methods during the study period (hormonal contraception, IUD (intrauterine device) or IUS (intrauterine system), tubal ligation, dual protection (using a combination of male condom, female condom, cervical cap, contraceptive diaphragm, or contraceptive sponge)
- Pregnant or lactating women
- Subjects planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study period
- Subjects who have participated in other clinical trials within 30 days prior to participating in this study and have received an IP or medical device during the previous clinical studies
- Subjects directly related to the investigator (e.g. a dermatologist or plastic surgeon)
- Individuals who are not eligible for this study for any reason as per the Investigator's discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Active-Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of "ATGC-110" Compared to "Xeomin®" in Patients Who Need Moderate or Severe Glabellar Line Improvement
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- ATGC-110, Xeomin®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATGC-110Biological
Also called Clostridium Botulinum Type A
ATGC-110 is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.
Xeomin®Biological
Also called Incobotulinumtoxin A
Xeomin® is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use.
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(ATGC-110) | Experimental | ATGC-110 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) Receives: Biological: ATGC-110 |
| Incobotulinumtoxin A (Xeomin®) | Active comparator | Xeomin® will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) Receives: Biological: Xeomin® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: 4 weeks after the administration
Secondary outcomes (11)
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at weeks 8, 12, and 16 compared to the baseline
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at rest according to the investigator's on-site evaluation at weeks 4, 8, 12, and 16 compared to the baseline
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: 4, 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at maximum frown evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: 4, 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at rest evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
Measured: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown according to the investigator's on-site evaluation at week 4, 8, 12, and 16
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe.
Measured: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at rest according to the investigator's on-site evaluation at week 4, 8, 12, and 16
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Measured: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Measured: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at rest evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16
Independent evaluator will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Measured: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is improved ≥ 2 grade improvement according to the subject's evaluation at week 4, 8, 12, and 16
Subjects will assess their glabellar lines with Facial Wrinkle Scale (FWS) at rest; 0=none, 1=mild, 2=moderate or 3=severe.
Measured: 4, 8, 12 and 16 weeks after the administration
Evaluation of subjects' satisfaction at weeks 4, 8, 12, and 16
If the subject's satisfaction evaluation score is 6 points or higher, it is evaluated as satisfactory.
Measured: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is imporved ≥ 2 grade improvement at maximal frown according to the investigator's on-site and subject's evaluation at weeks 4, 8, 12, and 16
If the glabellar line score evaluated by the subject is +2 points or higher, it is evaluated as improved
Measured: 4, 8, 12 and 16 weeks after the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start11 Oct 2022
- Primary completion10 Feb 2023 (estimated)
- Study completion10 Jun 2023 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATGC Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623410
- Sponsor's protocol ID
- CBAP-PLN-002
- Status last verified
- Feb 2023
- First submitted
- 13 Nov 2022
- Last updated
- 3 Feb 2023
- 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 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active-Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of "ATGC-110" Compared to "Xeomin®" in Patients Who Need Moderate or Severe Glabellar Line Improvement
- ClinicalTrials.gov ID
- NCT05623410
- Acronym / sponsor ID
- CBAP-PLN-002
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (actual)
- Lead sponsor
- ATGC Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 10 Feb 2023 (estimated)
- Study completion
- 10 Jun 2023 (estimated)
- First posted
- 21 Nov 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.
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Xeomin for a total of 16 weeks after the administration in treatment of glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum toxin type A(ATGC-110) | Experimental | Biological: ATGC-110ATGC-110 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) |
| Incobotulinumtoxin A (Xeomin®) | Active comparator | Biological: Xeomin®Xeomin® 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 (3 listed)
- Male and female subjects aged between 19 to 65 years
- Subjects assigned a glabellar line severity grade of 2 or greater (moderate) at maximum frown assessed by the Investigator
- Subjects who provide written consent to voluntarily participate in the study after receiving and understanding a detailed explanation of the study
Key exclusion criteria (23 listed)
- Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy etc.)
- Subjects with the history of eyelid paralysis or ptosis
- Subjects with significant facial asymmetry
- Subjects whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
- Infection, dermatological condition or scar at the treatment injection sites
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 |
|---|---|---|
| ATGC-110Also: Clostridium Botulinum Type AATGC-110 is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use. | Biological | Botulinum toxin type A(ATGC-110) |
| Xeomin®Also: Incobotulinumtoxin AXeomin® is a prescription medicine that is injected into muscles and used to improve the moderate to severe glabellar lines. It should be reconstituted with sterile, preservative-free 0.9% saline before use. | Biological | Incobotulinumtoxin A (Xeomin®) |
Primary outcome
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline
Time frame: 4 weeks after the administration
Investigators will assess subjects' glabellar lines with Facial Wrinkle Scale (FWS) at maximal frown; 0=none, 1=mild, 2=moderate or 3=severe. Only the subjects whose FWS score is 0- or 1-grade when it's assessed and ≥ 2-grade improvement from baseline will be defined as their glabellar lines are improved.
11 secondary outcomes
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at weeks 8, 12, and 16 compared to the baseline
Time frame: 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at rest according to the investigator's on-site evaluation at weeks 4, 8, 12, and 16 compared to the baseline
Time frame: 4, 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at maximum frown evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline
Time frame: 4, 8, 12 and 16 weeks after the administration
Improvement rate (%) of glabellar lines at rest evaluated through photographs by the independent evaluator at weeks 4, 8, 12, and 16 compared to the baseline
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown according to the investigator's on-site evaluation at week 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at rest according to the investigator's on-site evaluation at week 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at maximal frown evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is 0- or 1-grade at rest evaluated through photographs by the independent evaluator at week 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is improved ≥ 2 grade improvement according to the subject's evaluation at week 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
Evaluation of subjects' satisfaction at weeks 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
The percentage of subjects whose FWS score is imporved ≥ 2 grade improvement at maximal frown according to the investigator's on-site and subject's evaluation at weeks 4, 8, 12, and 16
Time frame: 4, 8, 12 and 16 weeks after the administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- 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.
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 3 study testing ATGC-110 and Xeomin® in people with Glabellar Frown Lines, run by ATGC 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 3 inclusion and 23 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 3 Feb 2023. 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?
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?
Improvement rate (%) of glabellar lines at maximum frown according to the investigator's on-site evaluation at week 4 compared to the baseline (time frame: 4 weeks after the administration). 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 3 Feb 2023.