Glabellar Frown LinesPhase 3Head2HeadNCT00777803
NT 201 (Xeomin®/Bocouture®) in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
A Phase 3 study testing NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) and OnabotulinumtoxinA (Vistabel®) in people with Glabellar Frown Lines, run by Merz Pharmaceuticals GmbH at 17 sites in 3 countries.
Trial summary
NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) and OnabotulinumtoxinA (Vistabel®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 381 participants
- Where
- 17 sitesin 3 countries
- Study dates
- Nov 2008to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Women only
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on a 4-point facial wrinkle scale) as assessed by the investigator's rating: 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe'.
Main Exclusion Criteria:
- Marked facial asymmetry.
- Ptosis of eyelid and/or eyebrow.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
Germany9 sites
Study site
Bad Soden
Study site
Böblingen
Study site
Cologne
Study site
Darmstadt
Study site
Frankfurt
Study site
Korschenbroich
Study site
Ludwigshafen
Study site
Munich
Study site
Wuppertal
Austria4 sites
Study site
Baden
Study site
Krems
Study site
Salzburg
Study site
Vienna
United Kingdom4 sites
Study site
Glasgow
Study site
Manchester
Study site
Suttion Coldfield
Study site
Winchester
About this study
Official title: A Prospective, Multicenter, Randomized, Rater- and Subject-Blind, Parallel Group Trial to Investigate the Non-Inferiority of NT 201, Free of Complexing Proteins, in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)), OnabotulinumtoxinA (Vistabel®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))Drug
Also called "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"
NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
OnabotulinumtoxinA (Vistabel®)Drug
Also called "BOTOX® Cosmetic", "Botulinum toxin type A (900 kiloDalton)"
OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles.
| Study group | Role | What they receive |
|---|---|---|
| IncobotulinumtoxinA (Xeomin®/Bocouture®) | Experimental | IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection. Receives: Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) |
| OnabotulinumtoxinA (Vistabel®) | Active comparator | OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection. Receives: Drug: OnabotulinumtoxinA (Vistabel®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder by Independent Rater's Assessment at Maximum Frown at Week 4
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 4 weeks after injection
Secondary outcomes (13)
Responder by Independent Rater's Assessment at Maximum Frown at Week 12
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 12 weeks after injection
Responder by Independent Rater's Assessment at Rest at Week 4
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 4 weeks after injection
Responder by Independent Rater's Assessment at Rest at Week 12
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 12 weeks after injection
Responder by Investigator's Assessment at Maximum Frown at Week 4
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 4 weeks after injection
Responder by Investigator's Assessment at Maximum Frown at Week 12
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 12 weeks after injection
Responder by Investigator's Assessment at Rest at Week 4
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 4 weeks after injection
Responder by Investigator's Assessment at Rest at Week 12
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at rest rated by the investigator. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 12 weeks after injection
Responder by Patient's Assessment at Maximum Frown at Week 4
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 4 weeks after injection
Responder by Patient's Assessment at Maximum Frown at Week 12
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter at maximum frown rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 12 weeks after injection
Responder by Patient's Assessment at Rest at Week 4
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at rest rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 4 weeks after injection
Response by Patient's Assessment at Rest at Week 12
The Outcome Measure Data Table describes the number of responders. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 12 weeks thereafter rated by the patient. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
Measured: 12 weeks after injection
Responder by Patient's Global Assessment at Week 4
The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 4 weeks after treatment rated by the patient.
Measured: 4 weeks after injection
Responder by Patient's Global Assessment at Week 12
The Outcome Measure Data Table describes the number of responders. A response is defined as a score of at least +2 (moderate improvement) on a 9-point scale (range from +4 complete improvement to -4 very marked worsening) 12 weeks after treatment rated by the patient.
Measured: 12 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glabellar Frown 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, Outcomes assessor
- Enrolment
- 381 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Expert, Study director, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777803
- Sponsor's protocol ID
- MRZ 60201 GL_3002
- Other IDs
- 2008-002713-40, 2008
- Acronym
- Head2Head
- Status last verified
- Mar 2012
- First submitted
- 21 Oct 2008
- Last updated
- 8 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sattler G, Callander MJ, Grablowitz D, Walker T, Bee EK, Rzany B, Flynn TC, Carruthers A. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg. 2010 Dec;36 Suppl 4:2146-54. doi: 10.1111/j.1524-4725.2010.01706.x.
PubMed 21134045
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Rater- and Subject-Blind, Parallel Group Trial to Investigate the Non-Inferiority of NT 201, Free of Complexing Proteins, in Comparison With Clostridium Botulinum Toxin Type A in the Treatment of Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT00777803
- Acronym / sponsor ID
- Head2Head / MRZ 60201 GL_3002
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 381 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Oct 2008 (estimated)
- Results
- Posted 10 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NT 201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), is a Botulinum toxin type A preparation free of complexing proteins (150 kiloDalton). Injected into the muscle, NT201 causes a reversible local relaxation of the injected muscle. Botulinum toxin type A is used for aesthetic treatment of mimic wrinkles and in the therapy of neurologic diseases. This study will investigate the safety and efficacy (non-inferiority) of NT 201 in comparison with OnabotulinumtoxinA (Vistabel®) in the treatment of glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IncobotulinumtoxinA (Xeomin®/Bocouture®) | Experimental | Drug: NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))IncobotulinumtoxinA (Xeomin®/Bocouture®), 24 units; mode of administration: intramuscular injection. |
| OnabotulinumtoxinA (Vistabel®) | Active comparator | Drug: OnabotulinumtoxinA (Vistabel®)OnabotulinumtoxinA (Vistabel®), 24 units; mode of administration: intramuscular injection. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®))Also: "Botulinum toxin type A (150 kiloDalton), free from complexing proteins"NT201, also known as IncobotulinumtoxinA (Xeomin®/Bocouture®), active ingredient: Clostridium botulinum neurotoxin type A free from complexing proteins, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles. | Drug | IncobotulinumtoxinA (Xeomin®/Bocouture®) |
| OnabotulinumtoxinA (Vistabel®)Also: "BOTOX® Cosmetic", "Botulinum toxin type A (900 kiloDalton)"OnabotulinumtoxinA (Vistabel®), active ingredient: Clostridium botulinum neurotoxin type A, powder for solution for injection dose, 24 units; one injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Of the 0.6 mL total injection volume, an aliquot of 0.15 mL was administered in the procerus muscle, aliquots of 0.125 mL were administered in the medial part of the both corrugator muscles and aliquots of 0.1 mL were administered in the middle part of both corrugator muscles. | Drug | OnabotulinumtoxinA (Vistabel®) |
Primary outcome
Responder by Independent Rater's Assessment at Maximum Frown at Week 4
Time frame: 4 weeks after injection
The Outcome Measure Data Table describes the number of responders. A subject is a responder if at least 2 out of 3 independent rater identified a response. A response is defined as an improvement of at least one point on a 4-point facial wrinkle scale from baseline to 4 weeks thereafter at maximum frown. The scale comprises the items 0 = 'none', 1 = 'mild', 2 = 'moderate', 3 = 'severe' wrinkles.
13 secondary outcomes
Responder by Independent Rater's Assessment at Maximum Frown at Week 12
Time frame: 12 weeks after injection
Responder by Independent Rater's Assessment at Rest at Week 4
Time frame: 4 weeks after injection
Responder by Independent Rater's Assessment at Rest at Week 12
Time frame: 12 weeks after injection
Responder by Investigator's Assessment at Maximum Frown at Week 4
Time frame: 4 weeks after injection
Responder by Investigator's Assessment at Maximum Frown at Week 12
Time frame: 12 weeks after injection
Responder by Investigator's Assessment at Rest at Week 4
Time frame: 4 weeks after injection
Responder by Investigator's Assessment at Rest at Week 12
Time frame: 12 weeks after injection
Responder by Patient's Assessment at Maximum Frown at Week 4
Time frame: 4 weeks after injection
Responder by Patient's Assessment at Maximum Frown at Week 12
Time frame: 12 weeks after injection
Responder by Patient's Assessment at Rest at Week 4
Time frame: 4 weeks after injection
Response by Patient's Assessment at Rest at Week 12
Time frame: 12 weeks after injection
Responder by Patient's Global Assessment at Week 4
Time frame: 4 weeks after injection
Responder by Patient's Global Assessment at Week 12
Time frame: 12 weeks after injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21134045Sattler G, Callander MJ, Grablowitz D, Walker T, Bee EK, Rzany B, Flynn TC, Carruthers A. Noninferiority of incobotulinumtoxinA, free from complexing proteins, compared with another botulinum toxin type A in the treatment of glabellar frown lines. Dermatol Surg. 2010 Dec;36 Suppl 4:2146-54. doi: 10.1111/j.1524-4725.2010.01706.x.
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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.
Medical Expert study director
Merz Pharmaceuticals GmbH
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NT 201 (IncobotulinumtoxinA (Xeomin®/Bocouture®)) and OnabotulinumtoxinA (Vistabel®) in people with Glabellar Frown Lines, run by Merz Pharmaceuticals GmbH at 17 sites in 3 countries.
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 8 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Austria, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Responder by Independent Rater's Assessment at Maximum Frown at Week 4 (time frame: 4 weeks after injection). 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 NCT00777803, 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 8 Mar 2012.