Crow's Feet LinesPhase 3NCT03184363
Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines(Extension Study)
A Phase 3 study testing Clostridium Botulinum A Toxin in people with Crow's Feet Lines and Glabellar Lines, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crow's Feet Lines, Glabellar Lines
- What is being tested?
- Clostridium Botulinum A Toxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Jul 2017to Dec 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of at least 18 to 75 years old
- moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
- moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator
- Subject who has completed phase 3 study for CFL.
Who cannot join
None listed.
About this study
Official title: Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines: Multi-center, Single Arm, Open, Extension Study
The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.
- Conditions
- Crow's Feet Lines, Glabellar Lines
- Being tested
- Clostridium Botulinum A Toxin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clostridium Botulinum A ToxinDrug
Clostridium Botulinum A Toxin
| Study group | Role | What they receive |
|---|---|---|
| Clostridium Botulinum A Toxin | Experimental | Clostridium Botulinum A Toxin Receives: Drug: Clostridium Botulinum A Toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject Assessment of Satisfaction of Appearance
Subject Assessment of Satisfaction of Appearance
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study startJul 2017 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionDec 2017 (estimated)
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.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184363
- Sponsor's protocol ID
- DW_DWP450005E
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DWP450 for Treating Crows Feet Lines(CFL) in Combination With Glabellar Lines: Multi-center, Single Arm, Open, Extension Study
- ClinicalTrials.gov ID
- NCT03184363
- Acronym / sponsor ID
- DW_DWP450005E
- Conditions
- Crow's Feet Lines, Glabellar Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Jul 2017 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jun 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.
The purpose of this study is to explore the Efficacy and Safety of DWP450 for treating Crows Feet Lines(CFL) in combination with glabellar line(GL) as extension study of phase 3 study for CFL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clostridium Botulinum A Toxin | Experimental | Drug: Clostridium Botulinum A ToxinClostridium Botulinum A Toxin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of at least 18 to 75 years old
- moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
- moderate-to-severe GL at maximum frawn on the FWS as rated by the investigator
- Subject who has completed phase 3 study for CFL.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Clostridium Botulinum A ToxinClostridium Botulinum A Toxin | Drug | Clostridium Botulinum A Toxin |
Primary outcome
Subject Assessment of Satisfaction of Appearance
Time frame: At 4 weeks
Subject Assessment of Satisfaction of Appearance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Individual participant dataSharing planned: Undecided
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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
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clostridium Botulinum A Toxin in people with Crow's Feet Lines and Glabellar Lines, run by Daewoong Pharmaceutical Co. LTD..
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 0 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: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Subject Assessment of Satisfaction of Appearance (time frame: At 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 12 Jun 2017.