Moderate to Severe Glabellar LinePhase 3NCT01629875

Efficacy and Safety of DWP450 Compared With Botox in Moderate to Severe Glabellar Line

A Phase 3 study testing Generic equivalent of Clostridium Botulinum A Toxin and Botox (Clostridium Botulinum A Toxin) in people with Moderate to Severe Glabellar Line, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients. Read more about this study

Who is it for?: Ages 20 to 65 years
Conditions the study is for: Moderate to Severe Glabellar Line
What is being tested?: Generic equivalent of Clostridium Botulinum A Toxin and Botox (Clostridium Botulinum A Toxin)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 268 participants
Where: 1 siteSouth Korea
Study dates: Mar 2012to Nov 2012
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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Chung-Ang University Hospital
Seoul

Other trials in South Korea

About this study

Official title: Efficacy and Safety of DWP450 Compared With Botox in Patients With Moderate to Severe Glabellar Line: Active Controlled, Double-blind, Randomized, Multi-center, Phase I/III Clinical Trial

The purpose of this study was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.

Conditions: Moderate to Severe Glabellar Line
Being tested: Generic equivalent of Clostridium Botulinum A Toxin, Botox (Clostridium Botulinum A Toxin)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Generic equivalent of Clostridium Botulinum A ToxinDrug
Botox (Clostridium Botulinum A Toxin)Drug

Study groups in NCT01629875
Study group	Role	What they receive
DWP450	Experimental	Not described Receives: Drug: Generic equivalent of Clostridium Botulinum A Toxin
Botox	Active comparator	Not described Receives: Drug: Botox (Clostridium Botulinum A Toxin)

What is being measured

The primary outcome is the main question the study is designed to answer.

At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
Measured: At 4 weeks

Secondary outcomes (1)

At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
Measured: At 8, 12, 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Nov 2012

First posted28 Jun 2012 (estimated)
Study startMar 2012
Primary completionAug 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderate to Severe Glabellar LineStudies 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: Randomised
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 268 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01629875
Sponsor's protocol ID: DW_DWP450001
Status last verified: Nov 2012
First submitted: 26 Jun 2012
Last updated: 7 Nov 2012
Results posted: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines

All Moderate to Severe Glabellar Line trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of DWP450 Compared With Botox in Patients With Moderate to Severe Glabellar Line: Active Controlled, Double-blind, Randomized, Multi-center, Phase I/III Clinical Trial
ClinicalTrials.gov ID: NCT01629875
Acronym / sponsor ID: DW_DWP450001
Conditions: Moderate to Severe Glabellar Line
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 268 participants (estimated)
Lead sponsor: Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Aug 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 28 Jun 2012 (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 was to observe Efficacy and safety of DWP450 compared with Botox in moderate to severe glabellar line patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
DWP450	Experimental	Drug: Generic equivalent of Clostridium Botulinum A Toxin
Botox	Active comparator	Drug: Botox (Clostridium Botulinum A Toxin)

Who may qualify

Ages: 20 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Generic equivalent of Clostridium Botulinum A Toxin	Drug	DWP450
Botox (Clostridium Botulinum A Toxin)	Drug	Botox

Primary outcome

At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
Time frame: At 4 weeks
At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment

1 secondary outcome

At 8, 12, 16 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment
Time frame: At 8, 12, 16 weeks

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 7 Nov 2012.

Related trials for Moderate to Severe Glabellar Line

RecruitingPhase 2
A Study to Assess the Safety and Efficacy of Co-Reconstituted TrenibotulinumtoxinE and OnabotulinumtoxinA in Adult Participants With Moderate to Severe Upper Facial Lines
Upper Facial Lines, Glabellar Lines
RecruitingPhase 3
To Evaluate HU-045 With Moderate to Severe Glabellar Lines
Glabellar Lines
Active, not recruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar Lines
RecruitingPhase 3
Efficacy and Safety of Recombinant Botulinum Toxin Type A (Eveotox) for Injection to Treat Moderate to Severe Glabellar Lines
Moderate to Severe Glabellar Lines
RecruitingPhase 3
A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Moderate to Severe Glabellar 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?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 7 Nov 2012. 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?

At 4 weeks, Glabellar line improvement rate at maximum frown confirmed with investigator's live severity assessment (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?

On the ClinicalTrials.gov record for NCT01629875.

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 7 Nov 2012.