Moderate to Severe Glabellar LinesPhase 1/2NCT03970876
Safety and Efficacy Study of ATGC-100 for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
A Phase 1/2 study testing ATGC-100 and Botox® in people with Moderate to Severe Glabellar Lines, run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Moderate to Severe Glabellar Lines
- What is being tested?
- ATGC-100 and Botox®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Apr 2019to 23 Dec 2019
- 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
- Healthy males and females aged between 19 to 65 years old
- Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
- Subjects who voluntarily signed the informed consent
Who cannot join
- Subjects with general neuromuscular synaptic disorders
- Presence or history of eyelid and/or ptosis
- Subjects with noticeable facial asymmetry
- Inability to substantially lessen glabellar frown lines even by physically spreading apart
- Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, Aminoglycoside antibiotics
- Subjects who are taking Anti-Coagulant and Anti-Platelet agent
Show all 14Show fewer
- Subjects who have taken Aspirin and NSAIDs within 7 days prior to administration of investigational drug
- Subjects with skin disorders at the injection site
- Subjects with previous treatment of Face Lifting, Permanent Implant, and/or Filler in glabellar region
- Subjects with prior filler treatments which would have interfered with the evaluation of the efficacy of the study treatment
- Any other planned facial aesthetic procedure in the glabellar area during the trial period
- Previous treatment with botulinum toxin in the forehead within the last 5 months or any planned treatment during the study period
- A history of drug or alcohol abuse
- Condition including anxiety disorder, or any other significant psychiatric disorder (e.g. depression), in the investigator's opinion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).
- Conditions
- Moderate to Severe Glabellar Lines
- Being tested
- ATGC-100, Botox®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATGC-100Biological
Clostridium Botulinum Type A
Botox®Biological
Clostridium Botulinum Type A
| Study group | Role | What they receive |
|---|---|---|
| ATGC-100 (Phase I/II) | Experimental | ATGC-100 will be injected to 5 glabellar lines (Each 4U/0.1ml, Total 20U/0.5ml) Receives: Biological: ATGC-100 |
| 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.
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
Measured: Up tp 12 weeks
Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)
Measured: 4 weeks after the injection
Secondary outcomes (4)
Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)
Measured: 8, 12 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II)
Measured: 4, 8, 12 weeks after the injection
Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II)
Measured: 4, 8, 12 weeks after the injection
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
Measured: Up tp 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start19 Apr 2019
- Primary completion11 Sep 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Glabellar 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
- EuBiologics Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970876
- Sponsor's protocol ID
- CBA-PLN-001
- Status last verified
- Apr 2019
- First submitted
- 28 May 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized, Double-Blind, Active-controlled, Single-Dose, Phase I/II, Non-Inferiority Study Comparing ATGC-100 and Botox for the Treatment of Moderate to Severe Glabellar Lines in Adult Subjects
- ClinicalTrials.gov ID
- NCT03970876
- Acronym / sponsor ID
- CBA-PLN-001
- Conditions
- Moderate to Severe Glabellar Lines
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 3 Jun 2019 (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.
Phase I/II clinical trial will be integrated and conducted. In phase I clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled and safety is assessed after 12 weeks of administration of 20U of ATGC-100. In phase II clinical trial, subjects with moderate to severe glabellar lines at maximum frown are enrolled, and efficacy and safety are assessed by comparing with Botox (Allergan).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATGC-100 (Phase I/II) | Experimental | Biological: ATGC-100ATGC-100 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 (3 listed)
- Healthy males and females aged between 19 to 65 years old
- Subjects attaining ≥ grade 2 in the investigator's rating of the severity of glabellar line at maximum frown
- Subjects who voluntarily signed the informed consent
Key exclusion criteria (14 listed)
- Subjects with general neuromuscular synaptic disorders
- Presence or history of eyelid and/or ptosis
- Subjects with noticeable facial asymmetry
- Inability to substantially lessen glabellar frown lines even by physically spreading apart
- Subjects who have administered the following drugs within 4 weeks prior to screening: Muscle relaxants, Anti-cholinergic agents, Benzodiazepine and similar drugs, Benzamide drugs, Tetracycline antibiotics, Lincomycin antibiotics, 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 |
|---|---|---|
| ATGC-100Clostridium Botulinum Type A | Biological | ATGC-100 (Phase I/II) |
| Botox®Clostridium Botulinum Type A | Biological | Botox® (Phase II) |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I)
Time frame: Up tp 12 weeks
Glabellar line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)
Time frame: 4 weeks after the injection
4 secondary outcomes
Glabella line improvement rate at maximum frown confirmed with investigator's assessment (Phase II)
Time frame: 8, 12 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's assessment (Phase II)
Time frame: 4, 8, 12 weeks after the injection
Glabellar line improvement rate at rest confirmed with subject's assessment (Phase II)
Time frame: 4, 8, 12 weeks after the injection
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase II)
Time frame: Up tp 12 weeks
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 23 Mar 2021.
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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 ATGC-100 and Botox® in people with Moderate to Severe Glabellar Lines, run by EuBiologics 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 14 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 23 Mar 2021. 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?
Number of participants with treatment-related adverse events as assessed by CTCAE Version 5.0 (Phase I) (time frame: Up tp 12 weeks). 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 23 Mar 2021.