Skin AgingPhase 3NCT01237977
Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
A Phase 3 study testing Botulinum Toxin Type A(Meditoxin®) and Botulinum Toxin Type A(Botox®) in people with Skin Aging, run by Medy-Tox at 6 sites in South Korea.
Trial summary
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- Botulinum Toxin Type A(Meditoxin®) and Botulinum Toxin Type A(Botox®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 23 Nov 2009to 30 Sep 2010
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged between 20 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who can comply with the study procedures and visit schedule
- Patients who voluntarily sign the informed consent
Who cannot join
- 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)
- Patients with severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.)
- Patients who have bleeding tendency or taking anti-coagulant
- Patients who were injected with botulinum toxin within the past 3 months
- Patients with allergy or hypersensitivity to the investigational drugs or their components
- Female subjects who are pregnant or lactating. Female subjects of childbearing age who have a plan to get pregnant during the study period, or do not use available contraceptive methods (Women of childbearing age should have negative urine pregnancy test results at baseline visit (0 week) prior to the first injection.)
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- Patients with the history of facial nerve paralysis or the symptoms of eyelid ptosis
- Patients with skin disorders or infection at the injection site
- Patients who have received other procedures which may affect glabellar and forehead lines within 6 months
- Patients with the history of treatment of glabellar part(including forehead) like face lifting and permanent implant or with scars which may affect the treatment results
- Patients whose glabellar lines cannot be satisfactorily improved with physical method since the lines are not flattened even using hands
- Patients who have a plan to receive facial cosmetic procedures including dermal filler, photorejuvenation, chemical peeling and dermabrasion during the study period
- Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening or the five times the half life of a drug which was given to patient during the previous clinical trials
- Patients who are unable to communicate or follow the instructions
- Patients who are not eligible for this study based on the judgment of an investigator
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyoung-gi Do, 463-707
Kangbuk Samsung Medical Center
Seoul, 110-746
Sevrance Medical Center
Seoul, 120-749
St. Paul Hospital
Seoul, 130-709
Seoul Asan Medical Center
Seoul, 138-736
Chung-Ang University Yong-San Hospital
Seoul, 140-013
About this study
Official title: Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of "Meditoxin® Versus Botox® in the Treatment of Glabellar Lines
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
Read the detailed description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.
- Conditions
- Skin Aging
- Being tested
- Botulinum Toxin Type A(Meditoxin®), Botulinum Toxin Type A(Botox®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A(Meditoxin®)Drug
Also called Neuronox®, Siax®
single administration, Day 0, 20U
Botulinum Toxin Type A(Botox®)Drug
single administration, Day 0, 20U
| Study group | Role | What they receive |
|---|---|---|
| Botulinum toxin type A(Meditoxin®) | Experimental | Not described Receives: Drug: Botulinum Toxin Type A(Meditoxin®) |
| Botulinum toxin type A(Botox®) | Active comparator | Not described Receives: Drug: Botulinum Toxin Type A(Botox®) |
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 severity
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection
Measured: 0 and 4 weeks after the injection
Secondary outcomes (6)
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment at baseline, 8, 12 and 16 weeks after the injection
Measured: 0, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Measured: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment at baseline, 4, 8,12, 16 weeks after the injection
Measured: 0, 4, 8,12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity at baseline, 4, 8, 12 and 16 weeks after the injection
Measured: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate confirmed with subject's assessment
Glabellar line improvement rate confirmed with subject's assessment at 4, 8, 12 and 16 weeks after the injection
Measured: 4, 8, 12 and 16 weeks after the injection
Subject satisfaction rate
Subject satisfaction rate at 4, 8, 12 and 16 weeks after the injection
Measured: 4, 8, 12 and 16 weeks after the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study start23 Nov 2009
- Primary completion30 Aug 2010
- Study completion30 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Skin AgingStudies 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
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chang-Hun Huh, MD, Ph.D., Principal investigator, Seoul National University Bundang HospitalHoon Kang, MD, Ph.D., Principal investigator, St. Paul HospitalWon-Seok Kim, MD, Ph.D., Principal investigator, Kang-Buk Samsung Medical CenterJong-Hyun Won, MD, Ph.D., Principal investigator, Seoul Asan Medical CenterJoo-Hee Lee, MD, Ph.D., Principal investigator, Sevrance Medical CenterBeom-Joon Kim, MD, Ph.D., Principal investigator, Chung-Ang University Yong-San Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237977
- Sponsor's protocol ID
- CSP-MDTX-GL-0901
- Status last verified
- Mar 2019
- First submitted
- 4 Nov 2010
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62.
PubMed 12973229Kriegl L, Horst D, Kirchner T, Jung A. LEF-1 expression in basal cell carcinomas. Br J Dermatol. 2009 Jun;160(6):1353-6. doi: 10.1111/j.1365-2133.2009.09144.x. Epub 2009 Mar 30. No abstract available.
PubMed 19416246Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
PubMed 9463853Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available.
PubMed 884196
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Active Drug Comparative, Parallel Designed, Multi-center,Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of "Meditoxin® Versus Botox® in the Treatment of Glabellar Lines
- ClinicalTrials.gov ID
- NCT01237977
- Acronym / sponsor ID
- CSP-MDTX-GL-0901
- Conditions
- Skin Aging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2009 (actual)
- Primary completion
- 30 Aug 2010 (actual)
- Study completion
- 30 Sep 2010 (actual)
- First posted
- 10 Nov 2010 (estimated)
- 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.
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
Detailed description
The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 20U in middle of the forehead. The efficacy and safety are evaluated for 16weeks through 4 follow up visits.
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 |
|---|---|---|
| Botulinum toxin type A(Meditoxin®) | Experimental | Drug: Botulinum Toxin Type A(Meditoxin®) |
| Botulinum toxin type A(Botox®) | Active comparator | Drug: Botulinum Toxin Type A(Botox®) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged between 20 and 65
- Patients attaining ≥grade 2 (moderate) in the investigator's rating of the severity of glabella lines at maximum frown
- Patients who can comply with the study procedures and visit schedule
- Patients who voluntarily sign the informed consent
Key exclusion criteria (15 listed)
- 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)
- Patients with severe internal diseases (cardiovascular, respiratory, endocrine diseases etc.)
- Patients who have bleeding tendency or taking anti-coagulant
- Patients who were injected with botulinum toxin within the past 3 months
- Patients with allergy or hypersensitivity to the investigational drugs or their components
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 A(Meditoxin®)Also: Neuronox®, Siax®single administration, Day 0, 20U | Drug | Botulinum toxin type A(Meditoxin®) |
| Botulinum Toxin Type A(Botox®)single administration, Day 0, 20U | Drug | Botulinum toxin type A(Botox®) |
Primary outcome
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity
Time frame: 0 and 4 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment of glabellar line severity at baseline and 4 weeks after the injection
6 secondary outcomes
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment
Time frame: 0, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's live assessment of glabellar line severity
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate at maximum frown confirmed with investigator's photo assessment
Time frame: 0, 4, 8,12 and 16 weeks after the injection
Glabellar line improvement rate at rest confirmed with investigator's photo assessment of glabellar line severity
Time frame: 0, 4, 8, 12 and 16 weeks after the injection
Glabellar line improvement rate confirmed with subject's assessment
Time frame: 4, 8, 12 and 16 weeks after the injection
Subject satisfaction rate
Time frame: 4, 8, 12 and 16 weeks after the injection
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 28 Mar 2019.
- Results publication: PubMed 12973229Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98. doi: 10.1097/01.PRS.0000076504.79727.62.
- Results publication: PubMed 19416246Kriegl L, Horst D, Kirchner T, Jung A. LEF-1 expression in basal cell carcinomas. Br J Dermatol. 2009 Jun;160(6):1353-6. doi: 10.1111/j.1365-2133.2009.09144.x. Epub 2009 Mar 30. No abstract available.
- Results publication: PubMed 9463853Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Stat Med. 1998 Jan 15;17(1):101-10. doi: 10.1002/(sici)1097-0258(19980115)17:13.0.co;2-e.
- Results publication: PubMed 884196Landis JR, Koch GG. An application of hierarchical kappa-type statistics in the assessment of majority agreement among multiple observers. Biometrics. 1977 Jun;33(2):363-74. No abstract available.
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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.
Chang-Hun Huh, MD, Ph.D. principal investigator
Seoul National University Bundang Hospital
Hoon Kang, MD, Ph.D. principal investigator
St. Paul Hospital
Won-Seok Kim, MD, Ph.D. principal investigator
Kang-Buk Samsung Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum Toxin Type A(Meditoxin®) and Botulinum Toxin Type A(Botox®) in people with Skin Aging, run by Medy-Tox at 6 sites 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 15 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Glabellar line improvement rate at maximum frown confirmed with investigator's live assessment severity (time frame: 0 and 4 weeks after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01237977, which also lists 4 linked publications.
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 28 Mar 2019; AzTrials last refreshed its copy on 6 Nov 2026.