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IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

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ClinicalTrials.gov Identifier: NCT00770211
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : September 13, 2011
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Tracking Information
First Submitted Date  ICMJE October 8, 2008
First Posted Date  ICMJE October 9, 2008
Results First Submitted Date  ICMJE August 9, 2011
Results First Posted Date  ICMJE September 13, 2011
Last Update Posted Date October 7, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
Composite Endpoint Treatment Success (CETS) Constituted by 2 Variables: 2-point Responders at Maximum Frown (Frown as Much as Possible) at Day 30 by Investigator's Rating on the Facial Wrinkle Scale and the Patient's Assessment on 4-point Scale [ Time Frame: Baseline to Day 30 ]
Composite endpoint CETS constituted by two efficacy variables:
  1. The investigator's assessment on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3.
  2. Patient's assessment on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor.
A subject was a responder only if a 2-point improvement compared to baseline occurred simultaneously for both variables.
Original Primary Outcome Measures  ICMJE
 (submitted: October 8, 2008)
Investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale [ Time Frame: Assessment at Day 30 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2011)
  • Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS) [ Time Frame: Baseline to Day 30 ]
    The investigator's assessment at rest (no muscle action in the face, no frown at all) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.
  • 1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale [ Time Frame: Baseline to Day 30 ]
    Patient's assessment at rest (no muscle action in the face, no frown at all) on the 4-point scale in comparison to sample photos: 0 = No visible vertical line(s) at all (i.e. no visible upright line); 1 = Slightly visible vertical line(s) (i.e. slightly visible upright line); 2 = Moderate vertical line(s) with depression (i.e. upright line with deepening); 3 = Deep vertical line(s) and depression which cannot be effaced by spreading (i.e. cannot be smoothed out). A subject was a responder if a 1-point improvement occurred compared to baseline.
  • Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS [ Time Frame: Baseline to Day 30 ]
    The investigator's assessment at maximum frown (frown as much as possible) on the four-point FWS: none = 0, mild = 1, moderate = 2, severe = 3. A responder was defined as a subject with a rating of none = 0 or mild = 1.
  • 1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale [ Time Frame: Baseline to Day 30 ]
    Patient's assessment at maximum frown (frown as much as possible) on the 4-point scale in comparison to sample photos: 0 = No muscle action at all; 1 = Some even slight muscle action possible i.e. visible furrows; 2 = Moderately strong muscle action possible i.e. visible muscle bulges; 3 = Strong muscle action possible which may cause local pallor. A subject was a responder if a 1-point improvement occurred compared to baseline.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
Official Title  ICMJE A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Investigate the Efficacy and Safety of IncobotulinumtoxinA (Xeomin), Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines.
Brief Summary The study objective is to show the superior efficacy of IncobotulinumtoxinA (Xeomin) over placebo by evaluation of treatment success analyzing the investigator's rating on the Facial Wrinkle Scale and the patient's assessment on a 4-point scale. 255 female and male patients with moderate to severe glabellar frown lines will be randomized in a 2:1 ratio to receive one injection of IncobotulinumtoxinA (Xeomin) or placebo and will be followed up until day 120.
Detailed Description

The study was a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter phase 3 clinical trial. Approximately 285 females and males with moderate to severe glabellar frown lines at maximum frown were to be screened during a screening period of four months in order to randomize approximately 255 subjects into one treatment and one placebo group at a ratio of 2 : 1. After the single injection treatment with a total dose of 20 Units IncobotulinumtoxinA (Xeomin) or corresponding placebo, the subjects were observed over 120 days. During the study participation the subjects performed seven visits.

Eight (8) sites in the United States participated in this trial. The study was led by one Lead PI and a Co-Lead PI who was assisting the Lead PI. The role of the Lead PI and the Co-Lead PI was executed by one of the PIs of this study, respectively. The PI at each site was a medical doctor who was experienced in aesthetic dermatology, i.e. who had several years (>= 2 years) of experience in treatment of glabellar frown lines with BTX-A preparations. The PI was the person who led the team at one trial site and who was responsible for the conduct of the clinical trial at the site. The sub-investigator was a member of the team designated by the PI to perform important trial-related decisions. A maximum number of two sub-investigators could be authorized for injection and rating if necessary. At each site, ideally one investigator was to inject and rate all subjects. Injecting and rating sub-investigators had to be medical doctors with several years of experience in treatment of glabellar frown lines with BTX-A preparations. A subject had to be rated by the same investigator at all visits. Another phase 3 trial MRZ 60201-0724/1 (NCT00770029) with design and endpoints identical to those in this trial was performed in order to compare efficacy and safety results with a second study population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Moderate to Severe Glabellar Frown Lines
Intervention  ICMJE
  • Drug: IncobotulinumtoxinA (Xeomin) (20 Units)
    The treatment will be administered only once at day 0 at five injection sites in the glabellar area. The total dose of 20 Units IncobotulinumtoxinA (Xeomin) is reconstituted in a total injection volume of 0.5 mL that is to be injected to the five sites in equal aliquots of 0.1 mL.
    Other Name: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (20 Units)
  • Drug: Placebo
    The treatment will be administered only once at day 0 at five injection sites in the glabellar area. Volume of Placebo equivalent to IncobotulinumtoxinA (Xeomin).
Study Arms  ICMJE
  • 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
    Intervention: Drug: IncobotulinumtoxinA (Xeomin) (20 Units)
  • 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
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 21, 2010)
271
Original Estimated Enrollment  ICMJE
 (submitted: October 8, 2008)
255
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 or over
  • Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by investigator's rating: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe')
  • Moderate to severe glabellar frown lines at maximum frown (severity score of 2 or 3 on Facial Wrinkle Scale as assessed by patient's assessment: 0= 'none', 1= 'mild', 2= 'moderate', 3= 'severe')
  • Stable medical condition

Exclusion Criteria:

  • Previous treatment with Botulinum toxin of any serotype in the glabellar area within the last 8 month
  • Previous treatment with any facial aesthetic procedure (e.g. injection with biodegradable fillers, chemical peeling, photo rejuvenation) in the glabellar area within the last 12 month
  • Previous insertion of permanent material in the glabellar area (regardless of the time between previous treatment and this study)
  • Planned treatment with Botulinum toxin of any serotype in any other body region during the study period
  • Any surgery in the glabellar area including surgical removal of the corrugator, procerus, or depressor supercilii muscles or a combination of these, or scars in the glabellar area and the surrounding areas (including eye brow)
  • Any other planned facial aesthetic procedure during the trial period
  • Inability to substantially lessen glabellar frown lines even by physically spreading them apart
  • Marked facial asymmetry or ptosis of eyelid and/or eyebrow
  • History of facial nerve palsy
  • Any infection in the area of the injection sites
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00770211
Other Study ID Numbers  ICMJE MRZ 60201 - 0741 / 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merz Pharmaceuticals GmbH
Study Sponsor  ICMJE Merz Pharmaceuticals GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: William Hanke, MD
Principal Investigator: Rhoda Narins, MD
PRS Account Merz Pharmaceuticals GmbH
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP