HealthyPhase 3NCT00694148
Safety and Efficacy of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
A Phase 3 study testing NT 201 in people with Healthy, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
Trial summary
NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- NT 201
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jan 2009
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
- Stable medical condition
- Age: between 18 and 65 years (inclusively)
Who cannot join
- Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
- Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
- Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
- Any other planned cosmetic procedure in the upper third part of the face during the trial period
- Inability to substantially lessen glabellar frown lines even by physically spreading them apart
Show all 9Show fewer
- Marked facial asymmetry or ptosis of eyelid and/or eyebrow
- History of facial nerve palsy
- Any infection in the area of the injection sites
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dr. Matthias Imhof, Medico Palais Bad Soden
Bad Soden, Hesse, 65812
About this study
Official title: NT 201 is a Botulinum Toxin Type A Preparation Free of Complexing Proteins. Injected Into the Muscle, NT 201 Causes a Reversible Local Relaxation of the Injected Muscle. Botulinum Toxin Type A is Widely Used for Aesthetic Treatment of Mimic Wrinkles. This Study Will Investigate the Safety and Efficacy of NT 201 in the Treatment of Glabellar Frown Lines.
NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.
- Conditions
- Healthy
- Being tested
- NT 201
- Keywords
- Treatment of glabellar frown lines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201Drug
A Botulinum neurotoxin type A, free of complexing proteins
Detailed described in study protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's assessment
Measured: 4 weeks after initial injection session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2009
- Study completionJan 2009
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 HealthyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matthias Imhof, MD, Principal investigator, Ästhetische Dermatologie, Medico Palais Bad Soden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694148
- Sponsor's protocol ID
- MRZ 60201 GL_3001
- Other IDs
- 2008-000549-73, 2008
- Status last verified
- Oct 2012
- First submitted
- 2 Jun 2008
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Imhof M, Kuhne U. A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. J Clin Aesthet Dermatol. 2011 Oct;4(10):28-34.
PubMed 22010053
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NT 201 is a Botulinum Toxin Type A Preparation Free of Complexing Proteins. Injected Into the Muscle, NT 201 Causes a Reversible Local Relaxation of the Injected Muscle. Botulinum Toxin Type A is Widely Used for Aesthetic Treatment of Mimic Wrinkles. This Study Will Investigate the Safety and Efficacy of NT 201 in the Treatment of Glabellar Frown Lines.
- ClinicalTrials.gov ID
- NCT00694148
- Acronym / sponsor ID
- MRZ 60201 GL_3001
- Conditions
- Healthy
- Keywords
- Treatment of glabellar frown lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 10 Jun 2008 (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.
NT 201 is a Botulinum toxin type A preparation free of complexing proteins. Injected into the muscle, NT 201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is widely used for aesthetic treatment of mimic wrinkles. This study will investigate the safety and efficacy of NT 201 in the treatment of glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- moderate to severe glabellar frown lines at maximum frown ((severity score of 2 or 3 on Facial Wrinkle Scale(FWS)as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'
- Stable medical condition
- Age: between 18 and 65 years (inclusively)
Key exclusion criteria (9 listed)
- Previous treatment with Botulinum toxin of any serotype in the upper third part of the face within the last 6 month
- Previous treatment with biodegradable fillers in the glabellar area within the last 12 month
- Previous insertion of permanent material in the glabellar area, including fat graft (regardless of the time between previous treatment and this study)
- Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area
- Any other planned cosmetic procedure in the upper third part of the face during the trial period
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 |
|---|---|---|
| NT 201A Botulinum neurotoxin type A, free of complexing proteins Detailed described in study protocol | Drug | – |
Primary outcome
Investigator's assessment
Time frame: 4 weeks after initial injection session
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 30 Oct 2012.
- Results publication: PubMed 22010053Imhof M, Kuhne U. A Phase III Study of IncobotulinumtoxinA in the Treatment of Glabellar Frown Lines. J Clin Aesthet Dermatol. 2011 Oct;4(10):28-34.
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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.
Matthias Imhof, MD principal investigator
Ästhetische Dermatologie, Medico Palais Bad Soden
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 NT 201 in people with Healthy, run by Merz Pharmaceuticals GmbH at 1 site in Germany.
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 3 inclusion and 9 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 30 Oct 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 Germany. 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?
Investigator's assessment (time frame: 4 weeks after initial injection session). 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 NCT00694148, 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 30 Oct 2012.