Crows Feet LinesPhase 2/3NCT02882893
Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines
A Phase 2/3 study testing Clostridium Botulinum A Toxin in people with Crows Feet Lines, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crows Feet Lines
- What is being tested?
- Clostridium Botulinum A Toxin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2016to Apr 2017
- Phase
- Phase 2/3
- 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
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Daewoong Clinical contact
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul
Daewoong Clinical
About this study
Official title: Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines: Active Controlled, Double-blind, Randomized, Multi-center, Phase II/III Clinical Trial
The purpose of this study is to evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL).
- Conditions
- Crows Feet 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
Also called BOTOX
Clostridium Botulinum A ToxinDrug
Also called NABOTA
| Study group | Role | What they receive |
|---|---|---|
| DWP450 | Experimental | Single-dose Receives: Drug: Clostridium Botulinum A Toxin |
| Botox | Active comparator | Single-dose Receives: Drug: Clostridium Botulinum A Toxin |
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 maximum smile as assessed by investigators
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 posted30 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionJan 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crows 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 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
- NCT02882893
- Sponsor's protocol ID
- DW_DWP450005
- Status last verified
- Aug 2016
- First submitted
- 25 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DWP450 for the Treatment of Crows Feet Lines: Active Controlled, Double-blind, Randomized, Multi-center, Phase II/III Clinical Trial
- ClinicalTrials.gov ID
- NCT02882893
- Acronym / sponsor ID
- DW_DWP450005
- Conditions
- Crows Feet Lines
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Aug 2016 (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 evaluate the Efficacy and Safety of DWP450 treatment of Crows Feet Lines(CFL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWP450 | Experimental | Drug: Clostridium Botulinum A ToxinSingle-dose |
| Botox | Active comparator | Drug: Clostridium Botulinum A ToxinSingle-dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female of at least 18 to 75 years old
- Bilaterally symmetrical moderate-to-severe CFL at maximum smile on the FWS as rated by the investigator
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 ToxinAlso: BOTOX | Drug | Botox |
| Clostridium Botulinum A ToxinAlso: NABOTA | Drug | DWP450 |
Primary outcome
Facial Wrinkle Scale(FWS) severity of Crow's feet lines(CFL) at maximum smile as assessed by investigators
Time frame: At 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Individual participant dataSharing planned: No
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.
Daewoong Clinical contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Clostridium Botulinum A Toxin in people with Crows Feet Lines, run by Daewoong Pharmaceutical Co. LTD. 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 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 30 Aug 2016. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Daewoong Clinical (8225508800), or a site near the patient. 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 maximum smile as assessed by investigators (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 30 Aug 2016.