Glabellar Frown LinesPhase 2NCT05217355
A Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
A Phase 2 study testing MBA-P01 (Botulinum toxin A) in people with Glabellar Frown Lines, run by Medytox Korea at 1 site in South Korea.
Trial summary
This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of glabellar lines. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- MBA-P01 (Botulinum toxin A)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Dec 2021to 22 Jun 2022
- Phase
- Phase 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 19 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who voluntarily sign the informed consent
Who cannot join
- Patients with the history of facial nerve paralysis
- Patients with the symptoms of eyelid ptosis determined by the investigator
- Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin, or the inability to substantially lessen glabellar lines even by physically spreading them apart, as determined by the investigator
- Active skin disease or infection in the treatment area
- History of surgery which may habe altered the anatomy of the corrugator supercilia muscle or the procerus muscle or related nerve
- Prior treatment with permanent filers, synthetic implantation, and/or autologous fat transplantation in the treatment area
Show all 22Show fewer
- Subject who received the following drugs within 4 weeks prior to the screening
- muscle relaxant: Peripherally acting relaxants, Centrally acting muscle relaxants, skeletal muscle relaxants
- benzodiazepine: Diazepam, Chlodiazepoxide, Medazepam, Oxazepam, Potassium clorazepate, Lorazepam etc.
- Subject who takes Muscle relaxants and benzodiazepine stably for 4 weeks can participate the study
- Subject who reveived any of the below facial aesthetic treatments that, in the investigator's opinion, could interfere the evaluation of efficacy
- Prior treatment with fillers in the treatment area within 1 year prior to screening (CaHA, Hyaluronic acid, PLLA, PCL etc.)
- Facial resurfacing or skin tightening procedure with lase, light or radiofrequency-based system; or any medium depth or deep depth facial chemical peels in the upper face within 6 months prior to screening
- Subject who received Retinois following period
- Systemic drug delivery : within 6 months prior to the screening
- Local drug delivery : within 3 months prior to the screening
- Patients with medical conditions who may be at greater risk due to the administration of the investigational drugs (e.g.. diseases that may affect the neuromuscular action including Myasthenia Gravis, Lambert-Eaton Syndrome, Amyotrophic Lateral Sclerosis and motor neuropathy)
- Known immunization or hypersensitivity to any botulinum toxin preparations
- Subject who had botulinum toxin treatment within 6 months prior to the screening or planning to receive botulinum toxic treatment during the study period other than study treatment
- Female subjects who are pregnant or nursing, or planning a pregnancy during the study and female subjects of childbearing potential who are not willing to use acceptable form of sontraception
- Subject who are participating in other interventional clinical study or have participated in such a study within 30 dyas prior to screening
- Subjects who are not eligible for this study at the discretion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of glabellar lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- MBA-P01 (Botulinum toxin A), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBA-P01 (Botulinum toxin A)Drug
MBA-P01 will be injected into the Glabellar line
PlaceboDrug
Placebo will be injected into the Glabellar line
| Study group | Role | What they receive |
|---|---|---|
| MBA-P01 | Experimental | Experimental group, Dose: 20U Receives: Drug: MBA-P01 (Botulinum toxin A) |
| Placebo | Placebo comparator | Placebo gorup, Normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Wrinkle Scale(FWS) change
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
Measured: 4 weeks
Secondary outcomes (5)
Investigator-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
The investigator and participant evaluate the participant's GL severity using a 4-grade scale (0 to 3) where 0=none and 3 = severe.
Measured: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
Proportion of subject achieving at least 5 score in Participant-rated satisfaction
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 posted1 Feb 2022
- Study start28 Dec 2021
- Primary completion22 Jun 2022
- Study completion22 Jun 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medytox Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217355
- Sponsor's protocol ID
- MT14-KR21GBL201
- Status last verified
- Feb 2023
- First submitted
- 29 Nov 2021
- Last updated
- 24 Feb 2023
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MBA-P01 in Subjects With Moderate to Severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05217355
- Acronym / sponsor ID
- MT14-KR21GBL201
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medytox KoreaIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 22 Jun 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 1 Feb 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.
This study is intended to evaluate the efficacy and safety of MBA-P01 compared to placebo in treatment of 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 |
|---|---|---|
| MBA-P01 | Experimental | Drug: MBA-P01 (Botulinum toxin A)Experimental group, Dose: 20U |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo gorup, Normal saline |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged between 19 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who voluntarily sign the informed consent
Key exclusion criteria (22 listed)
- Patients with the history of facial nerve paralysis
- Patients with the symptoms of eyelid ptosis determined by the investigator
- Marked facial asymmetry, dermatochalasis, deep dermal scarring in the glabellar area, excessively thick sebaceous skin, or the inability to substantially lessen glabellar lines even by physically spreading them apart, as determined by the investigator
- Active skin disease or infection in the treatment area
- History of surgery which may habe altered the anatomy of the corrugator supercilia muscle or the procerus muscle or related nerve
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 |
|---|---|---|
| MBA-P01 (Botulinum toxin A)MBA-P01 will be injected into the Glabellar line | Drug | MBA-P01 |
| PlaceboPlacebo will be injected into the Glabellar line | Drug | Placebo |
Primary outcome
Facial Wrinkle Scale(FWS) change
Time frame: 4 weeks
Proportion of subjects achieving at least a 2-grade decrease from baseline in score of Facial Wrinkle Scale (FWS) (0:none to 3: severe) of Glabellar line at maximum frown
5 secondary outcomes
Investigator-rated improvement rate of glabellar lines at maximum frown
Time frame: Week 8, 12, 16
Investigator-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at maximum frown
Time frame: Week 4, 8, 12, 16
Participant-rated improvement rate of glabellar lines at rest
Time frame: Week 4, 8, 12, 16
Participant-rated satisfaction after treatment
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 24 Feb 2023.
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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 2 study testing MBA-P01 (Botulinum toxin A) in people with Glabellar Frown Lines, run by Medytox Korea 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 22 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 24 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. Some participants in this study may receive a placebo. 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 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?
Facial Wrinkle Scale(FWS) change (time frame: 4 weeks). 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 24 Feb 2023.