Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Lateral Periorbital Wrinkles |
Drug: IncobotulinumtoxinA (Xeomin) Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
- Response assessed by an independent rater at maximum smile at week 4 for either eye area compared to baseline. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
- Response assessed by the investigator at maximum smile for either eye area compared to baseline. [ Time Frame: Weeks 2, 4, 12, and 20 ] [ Designated as safety issue: No ]Responder: subjects with improvement of at least 1 point on a 4 point scale for lateral periorbital wrinkles.
- 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 ] [ Designated as safety issue: No ]Responder: subjects with at least a moderate improvement, i.e. a score of at least +2 on a 9 point Likert scale.
| Enrollment: | 111 |
| Study Start Date: | September 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IncobutolinumtoxinA (Xeomin), 4-injection scheme
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. |
Drug: 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)
|
|
Placebo Comparator: Placebo 4-injection scheme
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.
|
Drug: Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
|
|
Experimental: IncobotulinumtoxinA (Xeomin), 3-injection scheme
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. |
Drug: 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)
|
|
Placebo Comparator: Placebo 3-injection Scheme
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.
|
Drug: Placebo
Intramuscular injection at day 0, at 3 and 4 injection sites per eye.
|
Detailed Description:
Conducted in Europe
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| France | |
| Cannes, France | |
| Nice, France | |
| Paris, France | |
| Germany | |
| Duesseldorf, Germany | |
| Karlsruhe, Germany | |
| Munich, Germany | |
| Starnberg, Germany | |
| Italy | |
| Roma, Italy | |
| United Kingdom | |
| Bexley. Kent, United Kingdom | |
| Glasgow, United Kingdom | |
| London, United Kingdom | |
| Sutton Coldfield, United Kingdom | |
| Principal Investigator: | David Eccleston, MD | MediZen, Sutton Coldfield, United Kingdom |
More Information
No publications provided
| Responsible Party: | Merz Pharmaceuticals GmbH |
| ClinicalTrials.gov Identifier: | NCT00541723 History of Changes |
| Other Study ID Numbers: | MRZ 60201-0617/1, 2006-005396-17 |
| Study First Received: | October 8, 2007 |
| Last Updated: | March 7, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Botulinum Toxins, Type A Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013