Glabellar LinesPhase 1NCT05292638
Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
A Phase 1 study testing CKDB-501A and Botox® in people with Glabellar Lines, run by CKD Bio Corporation at 1 site in South Korea.
Trial summary
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in 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 Lines
- What is being tested?
- CKDB-501A and Botox®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Feb 2022to 10 Jun 2022
- Phase
- Phase 1
- 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
- Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)
Who cannot join
- Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
- History of facial nerve paralysis or ptosis
- Significant facial asymmetry
- Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
- Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
- Previous treatment with retinoids (isotretinoin, alitretinoin, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.
- Conditions
- Glabellar Lines
- Being tested
- CKDB-501A, Botox®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKDB-501ADrug
Intramuscular injection CKDB-501A
Botox®Drug
Intramuscular injection Botox®
| Study group | Role | What they receive |
|---|---|---|
| CKDB-501A | Experimental | Not described Receives: Drug: CKDB-501A |
| Botox® | Active comparator | Not described Receives: Drug: Botox® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
severity and frequency of reported adverse events
Measured: up to week 12
Secondary outcomes (5)
Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit
using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))
Measured: Week 4, 8, 12
Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit
using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))
Measured: Week 4, 8, 12
Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit
using the 4-point FWS (Facial Wrinkle Scale, range from 0(None) to 3(Severe))
Measured: Week 4, 8, 12
Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit
using the Subject Assessment 9-grade Scale(range from -4(very marked worsening) to +4(complete inprovement)
Measured: Week 4, 8, 12
Subject-assessed satisfaction scale at each follow-up visit
using the Subject Satisfaction 7-point Scale(range from 1(very dissatisfied) to 7 (very satisfied)
Measured: Week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start15 Feb 2022
- Primary completion10 Jun 2022
- Study completion10 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Active-controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CKD Bio Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- beomjoon Kim, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292638
- Sponsor's protocol ID
- CKDB-BAGL-101
- Status last verified
- Nov 2022
- First submitted
- 23 Feb 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Single-center Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines
- ClinicalTrials.gov ID
- NCT05292638
- Acronym / sponsor ID
- CKDB-BAGL-101
- Conditions
- Glabellar Lines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CKD Bio CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 10 Jun 2022 (actual)
- First posted
- 23 Mar 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.
A single-center, randomized, double-blind, single-injection, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Glabellar lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Active-controlled
| Arm | Type | Receives |
|---|---|---|
| CKDB-501A | Experimental | Drug: CKDB-501A |
| Botox® | Active comparator | Drug: Botox® |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with at least moderate glabellar frown lines at maximum frown using the severity score of at least 2(moderate) on the Facial Wrinkle Scale (4-point FWS)
Key exclusion criteria (6 listed)
- Any medical condition (e.g., myasthenia gravis, Lambert-Easton syndrome, amyotrophic lateral sclerosis, etc.) that can affect the neuromuscular function
- History of facial nerve paralysis or ptosis
- Significant facial asymmetry
- Subjects with skin abnormalities such as infection, dermatologic disorders, scars, etc. at potential injection sites
- Previous treatment with any serotype of botulinum toxin products within 24 weeks (6 months) prior to Screening or planning to receive treatment with botulinum toxin during the study period
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 |
|---|---|---|
| CKDB-501AIntramuscular injection CKDB-501A | Drug | CKDB-501A |
| Botox®Intramuscular injection Botox® | Drug | Botox® |
Primary outcome
Incidence of Adverse Events
Time frame: up to week 12
severity and frequency of reported adverse events
5 secondary outcomes
Proportion of subjects with improvement in investigator-assessed glabellar line severity at maximum frown at each follow-up visit
Time frame: Week 4, 8, 12
Proportion of subjects with improvement in investigator-assessed glabellar line severity at rest at each follow-up visit
Time frame: Week 4, 8, 12
Changes in the investigator-assessed glabellar line severity score from baseline at each follow-up visit
Time frame: Week 4, 8, 12
Proportion of subjects with improvement in subject's assessment of glabellar line severity at each follow-up visit
Time frame: Week 4, 8, 12
Subject-assessed satisfaction scale at each follow-up visit
Time frame: Week 4, 8, 12
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 17 Nov 2022.
- 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.
beomjoon Kim principal investigator
Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CKDB-501A and Botox® in people with Glabellar Lines, run by CKD Bio Corporation 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 1 inclusion and 6 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 17 Nov 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 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.
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?
Incidence of Adverse Events (time frame: up to week 12). 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 17 Nov 2022.