IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
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|ClinicalTrials.gov Identifier: NCT00430963|
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : October 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Glabellar Frown Lines||Drug: IncobotulinumtoxinA (Xeomin) (20 Units) Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial With an Open-label Extension Period to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||November 2007|
Placebo Comparator: Placebo
Placebo to IncobotulinumtoxinA (Xeomin) powder for solution for injection; dose: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection
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)
- Investigator's assessment according to the Facial Wrinkle Scale (FWS) [ Time Frame: Day 30 ]Responder: FWS score of 0 or 1.
- Patient's global assessment [ Time Frame: Day 30 ]Responder: subjects with a score of at least 2+.
- Investigator's assessment according to FWS [ Time Frame: Day 7, 60, 90, and 120 ]Responder: FWS score of 0 or 1.
- Patient's global assessment [ Time Frame: Day 7, 60, 90, and 120 ]Responder: subjects with a score of at least 2+.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00430963
|Merz Pharmaceuticals GmbH|
|Frankfurt, Germany, 60318|
|Study Director:||Medical Expert||Merz Pharmaceuticals GmbH|