Crow's Feet LinesPhase 3NCT03317574
MEDITOXIN® in Treatment of Crow's Feet Line
A Phase 3 study testing botulinum toxin type A in people with Crow's Feet Lines, run by Medy-Tox at 1 site in South Korea.
Trial summary
to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Crow's Feet Lines
- What is being tested?
- botulinum toxin type A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Aug 2017to 14 May 2018
- 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
- Male or female of at least 20 to 65 years old
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
Who cannot join
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Patients with allergy or hypersensitivity to the investigational drugs or their components
- Patients who have bleeding tendency or taking anti-coagulant
- 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.)
- Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
- 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
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Active Drug Controlled, Multi-center, Phase Ⅰ/Ⅲ Study to Determine the Efficacy and Safety of Meditoxin® in Treatment of Crow's Feet Line
to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line
- Conditions
- Crow's Feet Lines
- Being tested
- botulinum toxin type A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called MEDITOXIN
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
Also called BOTOX
24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
| Study group | Role | What they receive |
|---|---|---|
| MEDITOXIN | Experimental | Not described Receives: Drug: botulinum toxin type A |
| BOTOX | Active comparator | Not described Receives: Drug: botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale(FWS)
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start17 Aug 2017
- Primary completion1 Dec 2017
- Study completion14 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crow's Feet 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medy-Tox
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317574
- Sponsor's protocol ID
- MT01-KR17CFL903
- Status last verified
- Mar 2019
- First submitted
- 18 Oct 2017
- Last updated
- 27 Mar 2019
- 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 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Drug Controlled, Multi-center, Phase Ⅰ/Ⅲ Study to Determine the Efficacy and Safety of Meditoxin® in Treatment of Crow's Feet Line
- ClinicalTrials.gov ID
- NCT03317574
- Acronym / sponsor ID
- MT01-KR17CFL903
- Conditions
- Crow's Feet Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Medy-ToxIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 14 May 2018 (actual)
- First posted
- 23 Oct 2017 (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.
to determine the efficacy and safety of Meditoxin® in treatment of crow's feet line
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 |
|---|---|---|
| MEDITOXIN | Experimental | Drug: botulinum toxin type A |
| BOTOX | Active comparator | Drug: botulinum toxin type A |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female of at least 20 to 65 years old
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
Key exclusion criteria (7 listed)
- Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
- Patients with allergy or hypersensitivity to the investigational drugs or their components
- Patients who have bleeding tendency or taking anti-coagulant
- 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.)
- Patients who are participating in other clinical trials or have participated in other clinical trials 30 days before screening
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 AAlso: MEDITOXIN24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas | Drug | MEDITOXIN |
| botulinum toxin type AAlso: BOTOX24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas | Drug | BOTOX |
Primary outcome
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale(FWS)
Time frame: 4 weeks
The Investigator assessed the severity of the patient's Crow's Feet lines at maximum smile using the 4-point Facial Wrinkle Scale where 0=none, 1=mild, 2=moderate or 3=severe. The percentage of participants with a score of none or mild at Day 30 is reported.
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 27 Mar 2019.
Related trials for Crow's Feet Lines
RecruitingObservational study
Prospective, Non-interventional Study Assessing Perioral Rejuvenation Procedure
Perioral Wrinkles, Crow's Feet
Not yet recruitingPhase 4
A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
Ecchymosis After Periorbital Rejuvenation With Botulinum Toxin Type A, Crow's Feet Lines
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 botulinum toxin type A in people with Crow's Feet Lines, run by Medy-Tox 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 2 inclusion and 7 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 27 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 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?
Percentage of Participants Achieving None or Mild on the Investigator's Assessment of the Severity of Crow's Feet Lines (CFL) at Maximum Smile Using the Facial Wrinkle Scale(FWS) (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 27 Mar 2019.