Lateral Periorbital WrinklesPhase 3NCT00541723
Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
A Phase 3 study testing IncobotulinumtoxinA (Xeomin) in people with Lateral Periorbital Wrinkles, run by Merz Pharmaceuticals GmbH at 12 sites in 4 countries.
Trial summary
To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lateral Periorbital Wrinkles
- What is being tested?
- IncobotulinumtoxinA (Xeomin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Sep 2007to May 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Main Inclusion Criteria:
- Moderate (grade 2) to severe (grade 3) symmetrical lateral periorbital wrinkles assessed by the investigator according to the 4-point scale at maximum smile
Main Exclusion Criteria:
- Significant facial asymmetry
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Germany4 sites
Study site
Düsseldorf
Study site
Karlsruhe
Study site
Munich
Study site
Starnberg
United Kingdom4 sites
Study site
Bexley. Kent
Study site
Glasgow
Study site
London
Study site
Sutton Coldfield
About this study
Official title: A Prospective, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles
To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).
Read the detailed description
Conducted in Europe
- Conditions
- Lateral Periorbital Wrinkles
- Being tested
- IncobotulinumtoxinA (Xeomin), Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncobotulinumtoxinA (Xeomin)Drug
Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye)
PlaceboDrug
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
| Study group | Role | What they receive |
|---|---|---|
| IncobutolinumtoxinA (Xeomin), 4-injection scheme | Experimental | IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient:
Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 4 x 0.06 mL (4 x 3 units = 12 units); mode of administration: intramuscular injection. Receives: Drug: IncobotulinumtoxinA (Xeomin) |
| Placebo 4-injection scheme | Placebo comparator | Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 4 x 0.06 mL placebo solution; mode of administration: intramuscular injection. Receives: Drug: Placebo |
| IncobotulinumtoxinA (Xeomin), 3-injection scheme | Experimental | IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient:
Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 3 x 0.08 mL (3 x 4 units = 12 units); Mode of administration: intramuscular injection. Receives: Drug: IncobotulinumtoxinA (Xeomin) |
| Placebo 3-injection Scheme | Placebo comparator | Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 3 x 0.08 mL placebo solution; mode of administration: intramuscular injection. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Measured: Week 4
Secondary outcomes (2)
Response assessed by the investigator at maximum smile for either eye area compared to baseline.
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
Measured: Weeks 2, 4, 12, and 20
Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.
Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.
Measured: Weeks 2, 4, 12, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Periorbital WrinklesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz Pharmaceuticals GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Eccleston, MD, Principal investigator, MediZen, Sutton Coldfield, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541723
- Sponsor's protocol ID
- MRZ 60201-0617/1
- Other IDs
- 2006-005396-17
- Status last verified
- Mar 2012
- First submitted
- 8 Oct 2007
- Last updated
- 8 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
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, Randomized, Double-Blind, Multicenter Trial to Investigate the Efficacy and Safety of NT 201 in Comparison to Placebo and to Compare Two Different Application Schemes of NT 201 in the Treatment of Lateral Periorbital Wrinkles
- ClinicalTrials.gov ID
- NCT00541723
- Acronym / sponsor ID
- MRZ 60201-0617/1
- Conditions
- Lateral Periorbital Wrinkles
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Merz Pharmaceuticals GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 10 Oct 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.
To investigate the efficacy and safety of incobotulinumtoxinA (Xeomin) in comparison to placebo in the treatment of moderate to severe lateral periorbital wrinkles at maximum smile and to compare two different application schemes of Xeomin. Each subject will be treated on the right and left eye area, using the same dose but different application schemes (i.e. 3 or 4 injection sites).
Detailed description
Conducted in Europe
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 |
|---|---|---|
| IncobutolinumtoxinA (Xeomin), 4-injection scheme | Experimental | Drug: IncobotulinumtoxinA (Xeomin)IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 4 x 0.06 mL (4 x 3 units = 12 units); mode of administration: intramuscular injection. |
| Placebo 4-injection scheme | Placebo comparator | Drug: PlaceboPlacebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 4 x 0.06 mL placebo solution; mode of administration: intramuscular injection. |
| IncobotulinumtoxinA (Xeomin), 3-injection scheme | Experimental | Drug: IncobotulinumtoxinA (Xeomin)IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150kD), free of complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin Type A free of complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl); total volume 0.24 mL per side, i.e. 3 x 0.08 mL (3 x 4 units = 12 units); Mode of administration: intramuscular injection. |
| Placebo 3-injection Scheme | Placebo comparator | Drug: PlaceboPlacebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; total volume 0.24 mL per side, i.e. 3 x 0.08 mL placebo solution; mode of administration: intramuscular injection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- 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 |
|---|---|---|
| IncobotulinumtoxinA (Xeomin)Intramuscular injection at day 0, at 3 and 4 injection sites per eye (4 x 3 or 3 x 4 units = 12 units per eye) | Drug | IncobotulinumtoxinA (Xeomin), 3-injection scheme, IncobutolinumtoxinA (Xeomin), 4-injection scheme |
| PlaceboIntramuscular injection at day 0, at 3 and 4 injection sites per eye. | Drug | Placebo 3-injection Scheme, Placebo 4-injection scheme |
Primary outcome
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline.
Time frame: Week 4
Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
2 secondary outcomes
Response assessed by the investigator at maximum smile for either eye area compared to baseline.
Time frame: Weeks 2, 4, 12, and 20
Response assessed by the subject's global assessment at maximum smile for either eye area compared to baseline.
Time frame: Weeks 2, 4, 12, and 20
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 8 Mar 2012.
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.
David Eccleston, MD principal investigator
MediZen, Sutton Coldfield, United Kingdom
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IncobotulinumtoxinA (Xeomin) in people with Lateral Periorbital Wrinkles, run by Merz Pharmaceuticals GmbH at 12 sites in 4 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 12 sites in Germany, United Kingdom, France, Italy. 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 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?
Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline. (time frame: Week 4). 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 8 Mar 2012.