Glabellar Frown LinesPhase 1/2NCT04281095
A Comparative Study of Botulinum Neurotoxin Type A in Treatment of Moderate to Severe Glabellar Frown Lines
A Phase 1/2 study testing Botulinum toxin type A 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 Botox for a total of 12 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?
- Botulinum toxin type A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Nov 2019to 30 Apr 2020
- 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
- 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
- Subjects with the history of eyelid paralysis or ptosis
- Subjects with significant facial asymmetry
- Individuals whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
- 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 taking anticoagulants or antiplatelet agents (Use of low-dose aspirin (325 mg/day or less) to prevent blood clotting is allowed)
Show all 24Show fewer
- Subjects who have received aspirin or NSAIDs within 7 days prior to administration of the IP.
- Subjects with skin abnormalities such as infection at the injection site, dermatopathy, or scars.
- 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: facial plastic surgery such as tissue augmentation, brow lift, or dermal resurfacing.
- Within 6 months of screening: injection of dermal fillers with hyaluronic acid as the main ingredient.
- Within 12 months of screening: injection of dermal fillers with ingredients other than hyaluronic acid as the main ingredient.
- Individuals planning a facial cosmetic procedure (skin fillers, photorejuvenation, chemical/mechanical peeling, etc.) during the study period.
- Individuals who have received a botulinum toxin preparation within 5 months prior to screening or those who are expected to receive a botulinum toxin preparation for any other purpose than the indication of this study (glabellar lines).
- Subjects with the history of excessive alcohol consumption or drug addiction
- Individuals with an anxiety disorder or other significant psychiatric disorders (e.g., depression), which, in the Investigator's opinion, may affect study participation or objective assessment of efficacy outcomes
- Individuals who answered "yes" to any of the questions on the Columbia University Suicide Severity Rating Scale (C-SSRS) regarding a case within the past 12 months at the 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 who are allergic or sensitive to the IP or its components
- Individuals 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
- Individuals who have participated in other clinical trials within 3 months prior to participating in this study and have received an IP or medical device during the previous clinical studies
- 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 Phase I/II Randomized, Double Blind, Active-controlled, Single Center Clinical Trial for Evaluation of Safety and Efficacy of ATGC-110, An Intramuscularly Administered Clostridium Botulinum Neurotoxin Type A, in Adult Patients With Moderate to Severe Glabellar Frown Lines
Efficacy and safety of the investigational product, ATGC-110, was evaluated in comparison with Botox for a total of 12 weeks after the administration in treatment of glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(ATGC-110) | Experimental | Not described Receives: Drug: Botulinum toxin type A |
| Botulinum toxin type A | Active comparator | Not described Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Changes in the glabellar line severity at maximum frown from baseline to 4 weeks after the IP administration were evaluated by investigator
Measured: 0 and 4 weeks after the administration
Secondary outcomes (4)
Glabellar line improvement rate at maximum frown confirmed by investigator's live assessment
Changes in the glabellar line severity at maximum frown from baseline to 8 and 12 weeks after the IP administration were evaluated by investigator
Measured: 0, 8, 12 weeks after the administration
Glabellar line improvement rate at rest confirmed by investigator's live assessment
Changes in the glabellar line severity at rest from baseline to 4, 8 and 12 weeks after the IP administration were evaluated by investigator
Measured: 0, 4, 8, 12 weeks after the administration
Glabellar line improvement rate at rest confirmed by subject's assessment
Changes in the glabellar line severity at rest from baseline to 4, 8 and 12 weeks after the IP administration were evaluated by subjects
Measured: 0, 4, 8, 12 weeks after the administration
Subject satisfaction rate
Subjects fill out the satisfaction questionnaire
Measured: 0, 4, 8, 12 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 posted24 Feb 2020
- Study start1 Nov 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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
- ATGC Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281095
- Sponsor's protocol ID
- CBAP-PLN-001
- Status last verified
- Jul 2020
- First submitted
- 20 Feb 2020
- Last updated
- 9 Jul 2020
- 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 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Double Blind, Active-controlled, Single Center Clinical Trial for Evaluation of Safety and Efficacy of ATGC-110, An Intramuscularly Administered Clostridium Botulinum Neurotoxin Type A, in Adult Patients With Moderate to Severe Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT04281095
- Acronym / sponsor ID
- CBAP-PLN-001
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ATGC Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 24 Feb 2020 (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 Botox for a total of 12 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 | Drug: Botulinum toxin type A |
| Botulinum toxin type A | Active comparator | Drug: Botulinum toxin type A |
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 (24 listed)
- Subjects with diseases that may affect neuromuscular function, such as Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis, or motor neuropathy
- Subjects with the history of eyelid paralysis or ptosis
- Subjects with significant facial asymmetry
- Individuals whose glabellar lines cannot be satisfactorily improved with physical methods since lines are not flattened even using hands
- 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
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 |
|---|---|---|
| Botulinum toxin type ATotal of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each | Drug | Botulinum toxin type A, Botulinum toxin type A(ATGC-110) |
Primary outcome
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Time frame: 0 and 4 weeks after the administration
Changes in the glabellar line severity at maximum frown from baseline to 4 weeks after the IP administration were evaluated by investigator
4 secondary outcomes
Glabellar line improvement rate at maximum frown confirmed by investigator's live assessment
Time frame: 0, 8, 12 weeks after the administration
Glabellar line improvement rate at rest confirmed by investigator's live assessment
Time frame: 0, 4, 8, 12 weeks after the administration
Glabellar line improvement rate at rest confirmed by subject's assessment
Time frame: 0, 4, 8, 12 weeks after the administration
Subject satisfaction rate
Time frame: 0, 4, 8, 12 weeks after the administration
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 9 Jul 2020.
- 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 1/2 study testing Botulinum toxin type A 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 24 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 9 Jul 2020. 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 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?
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment (time frame: 0 and 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 9 Jul 2020.