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

NCT00770211 | Completed Phase 3 Results

• 1 other identifier: MRZ 60201 - 0741 / 1
• Study Type: interventional
• Target: 271
• Locations: 1 country
• Sites: 8

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.

Conditions

Moderate to Severe Glabellar Frown Lines

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline to Day 30

Secondary Outcomes (4)

• Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)

  Baseline to Day 30

• 1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale

  Baseline to Day 30

• Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS

  Baseline to Day 30

• 1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale

  Baseline to Day 30

Study Arms (2)

IncobotulinumtoxinA (Xeomin) (20 Units)

EXPERIMENTAL

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)

Placebo

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, corresponding to total placebo volume 0.5 mL; mode of administration: intramuscular injection

Drug: Placebo

Interventions

IncobotulinumtoxinA (Xeomin) (20 Units) DRUG

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.

Also known as: IncobotulinumtoxinA (Xeomin), also known as 'NT 201' or 'Botulinum toxin type A (150 kD), free from complexing proteins' (20 Units)

IncobotulinumtoxinA (Xeomin) (20 Units)

Placebo DRUG

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).

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merz Pharmaceuticals GmbH: lead

Study Sites (8)

About Skin Dermatoloy

Englewood, Colorado, 80113, United States

Location

Center for Cosmetic Enhancement

Aventura, Florida, 33180, United States

Location

Frederic Brandt

Coral Gables, Florida, 33146, United States

Location

Advanced Dermatology Research Institute

Lincolnshire, Illinois, 60069, United States

Location

Laser & Skin Surgery Center of Indiana

Carmel, Indiana, 46032, United States

Location

Joel Schlessinger

Omaha, Nebraska, 68144, United States

Location

Image Dermatology P.C.

Montclair, New Jersey, 07042, United States

Location

Rhoda Narins

White Plains, New York, 10604-2926, United States

Location

MeSH Terms

Interventions

incobotulinumtoxinA; Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Dr. Matthias Zerm
• Organization: Merz Pharmaceuticals GmbH

matthias.zerm@merz.de

0049-69-1503

Study Officials

• William Hanke, MD

  PRINCIPAL INVESTIGATOR

• Rhoda Narins, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 7, 2011
• Results First Posted: September 13, 2011

Record last verified: 2011-10

Locations

US (8)