Glabellar Frown LinesPhase 3NCT04830345
Efficacy and Safety of Botulinum Toxin at Moderate to Severe Glabellar Lines
A Phase 3 study testing ATGC-100 100U and Botox 100U in people with Glabellar Frown Lines, run by EuBiologics Co.,Ltd at 1 site in South Korea.
Trial summary
Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe 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?
- ATGC-100 100U and Botox 100U
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 Jun 2020to 1 Oct 2021
- 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
- Healthy male and female aged 19 to 65 years old
- Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening
- Participants willing to follow the study procedures and schedules
- Participants willing to give written informed consent to participate in the trial
Who cannot join
- Participants with severe glabellar lines that cannot be improved physical method
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- Participants with known hypersensitivity to any component of the study drug
- Participant who has skin disorder including infection and scar on injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines
Efficacy and safety of ATGC-100 are assessed in subjects with moderate to severe glabellar lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- ATGC-100 100U, Botox 100U
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATGC-100 100UBiological
Clostridium botulinum toxin type A
Botox 100UBiological
Clostridium botulinum toxin type A
| Study group | Role | What they receive |
|---|---|---|
| ATGC-100 100U | Experimental | ATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0 Receives: Biological: ATGC-100 100U |
| Botox 100U | Active comparator | Botox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0 Receives: Biological: Botox 100U |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with improvement of glabellar lines at maximum frown
Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)
Measured: 4 weeks post injection compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start29 Jun 2020
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 290 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
- NCT04830345
- Sponsor's protocol ID
- CBA-PLN-002
- Status last verified
- Mar 2021
- First submitted
- 31 Mar 2021
- Last updated
- 4 Apr 2022
- 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 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Non-inferiority, Phase 3 Clinical Trial to Compare the Efficacy and Safety of ATGC-100 Versus Botox in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT04830345
- Acronym / sponsor ID
- CBA-PLN-002
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- EuBiologics Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 5 Apr 2021 (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 ATGC-100 are assessed in subjects with moderate to severe glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATGC-100 100U | Experimental | Biological: ATGC-100 100UATGC-100 will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0 |
| Botox 100U | Active comparator | Biological: Botox 100UBotox inj. will be injected to 5 glabellar lines (each 4U/0.1mL; total 20U) at Day 0 |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male and female aged 19 to 65 years old
- Participants with Facial Wrinkle Scale (FWS) score of > 2 at maximum frown at screening
- Participants willing to follow the study procedures and schedules
- Participants willing to give written informed consent to participate in the trial
Key exclusion criteria (4 listed)
- Participants with severe glabellar lines that cannot be improved physical method
- Pregnant, lactating women or women of childbearing age not using a reliable method of contraception
- Participants with known hypersensitivity to any component of the study drug
- Participant who has skin disorder including infection and scar on injection site
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-100 100UClostridium botulinum toxin type A | Biological | ATGC-100 100U |
| Botox 100UClostridium botulinum toxin type A | Biological | Botox 100U |
Primary outcome
Proportion of patients with improvement of glabellar lines at maximum frown
Time frame: 4 weeks post injection compared to baseline
Improvement rate of glabellar lines at maximum frown with Physician's Facial wrinkle scale (FWS)
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 4 Apr 2022.
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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-100 100U and Botox 100U in people with Glabellar Frown 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 4 inclusion and 4 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 4 Apr 2022. 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?
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 patients with improvement of glabellar lines at maximum frown (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 4 Apr 2022.