Safety and Efficacy of IncobotulinumtoxinA (Xeomin) in the Treatment of Glabellar Frown Lines
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open-label, Multicenter, Repeat-dose Trial to Investigate the Safety and Efficacy of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines|
- - Safety endpoints - Investigator's assessment - Patient's assessment [ Time Frame: Assessment at days 30 and >84 ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: IncobotulinumtoxinA (Xeomin) (20 units)
IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% sodium chloride (NaCl), 20 units, total volume 0.5 mL, mode of administration: intramuscular injection
Drug: IncobotulinumtoxinA (Xeomin) (20 units)
Injection of a total of 20 Units incobotulinumtoxinA (Xeomin) on day one of each of up to eight cycles, reconstituted in a total injection volume of 0.5 mL administered in five equal parts of 0.1 mL to five predefined points of the glabellar area.
Other Name: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins (20 units)
This was a prospective, multicenter, open-label, non-control group design Phase 3 clinical study. Approximately 880 subjects who were to complete former studies in this program (370 subjects from studies MRZ 60201-0520/1 (8) and MRZ 60201-0527/1 (8) as well as approximately 510 subjects from studies MRZ 60201-0724/1 (10) and MRZ 60201-0741/1) (11) were expected to enroll in this study in 26 centers in the United States, Canada and Germany. Subjects with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four "feeder" studies in the frown line program were eligible to participate in this repeated dose study.
Each subject received a dose of 20 units incobotulinumtoxinA (Xeomin) for i.m. injection on Visit 1 (Day 0 of Cycle 1). Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles (one cycle ≥ 85 days). Intervals between treatments were at least three months or 12 weeks, i.e., ≥ 85 days. For a new treatment cycle to start, the subject had to request a re-injection. The investigator then had to assess if the glabellar frown lines had relapsed to 'moderate' or 'severe'. In this case, a new injection could be administered. The treatment duration per subject was 24 months and up to eight cycles for subjects enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 and 6 months and up to two cycles for subjects enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1, respectively. Subjects enrolled from studies MRZ 60201-0520/1 and MRZ 60201-0527/1 participated at least one year in the study whereas subjects enrolled from studies MRZ 60201-0724/1 and MRZ 60201-0741/1 participated for six months and up to two cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00512135
Show 25 Study Locations
|Principal Investigator:||Berthold Rzany, Prof. Dr. med Sc.M.||Division of Evidence Based Medicine dEBM, Department of Dermatology, Venerology and Allergology , Charité - University Medicine, Berlin, Germany|
|Principal Investigator:||Timothy Corcoran Flynn, MD|