Glabellar Frown LinesPhase 2NCT00430586
Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
A Phase 2 study testing Botulinum neurotoxin type A, free of complexing proteins in people with Glabellar Frown Lines, 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, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glabellar Frown Lines
- What is being tested?
- Botulinum neurotoxin type A, free of complexing proteins
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Aug 2007
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate to severe glabellar frown lines
Who cannot join
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
NT 201 is a botulinum toxin type A preparation free of complexing proteins, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.
- Conditions
- Glabellar Frown Lines
- Being tested
- Botulinum neurotoxin type A, free of complexing proteins, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum neurotoxin type A, free of complexing proteinsDrug
Also called BTX-A,, BoNT/A,, incobotulinumtoxinA (Xeomin)
Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
PlaceboDrug
Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
| Study group | Role | What they receive |
|---|---|---|
| 20 U NT 201 | Experimental | Not described Receives: Drug: Botulinum neurotoxin type A, free of complexing proteins |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| 10 U NT 201 | Experimental | Not described Receives: Drug: Botulinum neurotoxin type A, free of complexing proteins |
| 30 U NT 201 | Experimental | Not described Receives: Drug: Botulinum neurotoxin type A, free of complexing proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1).
The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
Measured: Baseline (Day 0) to Day 30
Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
Responders will be subjects with at least a 1-point improvement compared to Day 0.
The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
Measured: Baseline (Day 0) to Day 30
Secondary outcomes (2)
Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1).
Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint.
Measured: Baseline (Day 0) to Day 90
Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
Responders will be subjects with at least a 1-point improvement compared to Day 0.
Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint.
Measured: Baseline (Day 0) to Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startNov 2006
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Merz Pharmaceuticals, Study chair, Merz Pharmaceuticals GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430586
- Sponsor's protocol ID
- MRZ 60201-0527/1
- Status last verified
- Aug 2011
- First submitted
- 1 Feb 2007
- Last updated
- 3 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
- ClinicalTrials.gov ID
- NCT00430586
- Acronym / sponsor ID
- MRZ 60201-0527/1
- Conditions
- Glabellar Frown Lines
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Study completion
- Aug 2007 (actual)
- First posted
- 2 Feb 2007 (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, i.e. free of proteins other than the active toxin. Injected into the muscle, NT 201 causes local weakening to full paralysis depending on the administered dose. Botulinum toxin type A is widely used for aesthetic treatment of facial lines. This study will determine the optimal dose of NT 201 in the treatment of glabellar frown lines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 U NT 201 | Experimental | Drug: Botulinum neurotoxin type A, free of complexing proteins |
| Placebo | Placebo comparator | Drug: Placebo |
| 10 U NT 201 | Experimental | Drug: Botulinum neurotoxin type A, free of complexing proteins |
| 30 U NT 201 | Experimental | Drug: Botulinum neurotoxin type A, free of complexing proteins |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Moderate to severe glabellar frown lines
Key exclusion criteria (2 listed)
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
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 |
|---|---|---|
| Botulinum neurotoxin type A, free of complexing proteinsAlso: BTX-A,, BoNT/A,, incobotulinumtoxinA (Xeomin)Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site. | Drug | 10 U NT 201, 20 U NT 201, 30 U NT 201 |
| PlaceboSingle treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered. The total dose volume was administered in equal aliquots to the 5 injection sites. Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site. | Drug | Placebo |
Primary outcome
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
Time frame: Baseline (Day 0) to Day 30
Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
Time frame: Baseline (Day 0) to Day 30
Responders will be subjects with at least a 1-point improvement compared to Day 0. The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints.
2 secondary outcomes
Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Time frame: Baseline (Day 0) to Day 90
Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
Time frame: Baseline (Day 0) to Day 90
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 3 Aug 2011.
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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.
Merz Pharmaceuticals study chair
Merz Pharmaceuticals GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum neurotoxin type A, free of complexing proteins in people with Glabellar Frown Lines, 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 1 inclusion and 2 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 3 Aug 2011. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS) (time frame: Baseline (Day 0) to Day 30). The study lists 2 primary outcomes in all. 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 3 Aug 2011.