Crow's Feet LinesPhase 3NCT03408236
Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
A Phase 3 study testing Botulinum toxin type A in people with Crow's Feet Lines, run by Hugel at 1 site in South Korea.
Trial summary
To determine the efficacy and safety of Botulax® in treatment of crow's feet line Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- 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
- 240 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Jan 2018to 7 Jun 2019
- 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
- Male or female of at least 19 to 65 years old
- Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator
Who cannot join
- Subject with hypersensitivity to the investigational products or their components
- Female subject who are pregnant or lactating
- Subject who are unable to communicate or follow the instructions
- Subject 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: Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
To determine the efficacy and safety of Botulax® in treatment of crow's feet line
Read the detailed description
- Allocation: Randomized
- Masking: Double Blind
- 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 Botulax
Experimental
Also called Botox
Active Comparator
| Study group | Role | What they receive |
|---|---|---|
| Botulax | Experimental | Single dose Receives: Drug: Botulinum toxin type A |
| Botox | Active comparator | Single dose Receives: Drug: Botulinum toxin type A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators
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 as assessed by investigators
Measured: 4weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start17 Jan 2018
- Primary completion13 Dec 2018
- Study completion7 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408236
- Sponsor's protocol ID
- HG-BOTCFL-III1
- Status last verified
- Apr 2022
- First submitted
- 8 Jan 2018
- Last updated
- 15 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoo KH, Park SJ, Han HS, Won CH, Lee YW, Kim BJ. Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1587-1594. doi: 10.1111/jdv.17217. Epub 2021 Apr 12.
PubMed 33721365
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Active-controlled, Multicenter, Phase I/III Clinical Trial to Evaluate the Safety and Efficacy of Botulax® as Compared to Botox® in Subject With Moderate to Severe Crow's Feet Lines
- ClinicalTrials.gov ID
- NCT03408236
- Acronym / sponsor ID
- HG-BOTCFL-III1
- Conditions
- Crow's Feet Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- HugelIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 13 Dec 2018 (actual)
- Study completion
- 7 Jun 2019 (actual)
- First posted
- 23 Jan 2018 (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 Botulax® in treatment of crow's feet line
Detailed description
- Allocation: Randomized
- Masking: Double Blind
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulax | Experimental | Drug: Botulinum toxin type ASingle dose |
| Botox | Active comparator | Drug: Botulinum toxin type ASingle dose |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female of at least 19 to 65 years old
- Bilaterally symmetrical moderator-to-severe CFL at maximum smile on the FWS as rated by the investigator
Key exclusion criteria (4 listed)
- Subject with hypersensitivity to the investigational products or their components
- Female subject who are pregnant or lactating
- Subject who are unable to communicate or follow the instructions
- Subject who are not eligible for this study based on the judgment of an investigator
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: BotulaxExperimental | Drug | Botulax |
| Botulinum toxin type AAlso: BotoxActive Comparator | Drug | Botox |
Primary outcome
Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators
Time frame: 4weeks
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 as assessed by investigators
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 15 Apr 2022.
- Derived from this study: PubMed 33721365Yoo KH, Park SJ, Han HS, Won CH, Lee YW, Kim BJ. Randomized, double-blind, active-controlled, multicentre, phase III clinical trial with two stages to assess the safety and efficacy of letibotulinum toxin a vs. onabotulinum toxin a for subjects with moderate to severe crow's feet. J Eur Acad Dermatol Venereol. 2021 Jul;35(7):1587-1594. doi: 10.1111/jdv.17217. Epub 2021 Apr 12.
Related trials for Crow's Feet Lines
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A Real-World Study on Effect of Hirudoid on Ecchymosis After Treatment of Crow's Feet With Botulinum Toxin Type A
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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 Botulinum toxin type A in people with Crow's Feet Lines, run by Hugel 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 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 15 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?
Facial Wrinkle Scale(FWS) severity of crow's feet lines(CFL) at maxium smile as assessed by investigators (time frame: 4weeks). 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 NCT03408236, which also lists 1 linked publication.
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 15 Apr 2022.