Clinical trial NCT00770211: IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Moderate to Severe Glabellar Frown Lines
Lead sponsor: Merz Pharmaceuticals GmbH
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline to Day 30
Secondary outcomes:
measure: Responders at Rest at Day 30 by Investigator's Assessment on Facial Wrinkle Scale (FWS)
timeFrame: Baseline to Day 30
measure: 1-point Responders at Rest at Day 30 by Patient's Assessment on 4-point Scale
timeFrame: Baseline to Day 30
measure: Responders at Maximum Frown at Day 30 by Investigator's Rating on FWS
timeFrame: Baseline to Day 30
measure: 1-point Responders at Maximum Frown at Day 30 by Patient's Assessment on 4-point Scale
timeFrame: Baseline to Day 30
Other outcomes:
Locations:
city: Englewood
country: United States
facility: About Skin Dermatoloy
state: Colorado
city: Aventura
country: United States
facility: Center for Cosmetic Enhancement
state: Florida
city: Coral Gables
country: United States
facility: Frederic Brandt
state: Florida
city: Lincolnshire
country: United States
facility: Advanced Dermatology Research Institute
state: Illinois
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Omaha
country: United States
facility: Joel Schlessinger
state: Nebraska
city: Montclair
country: United States
facility: Image Dermatology P.C.
state: New Jersey
city: White Plains
country: United States
facility: Rhoda Narins
state: New York
Study officials:
name: William Hanke, MD
role: PRINCIPAL_INVESTIGATOR
name: Rhoda Narins, MD
role: PRINCIPAL_INVESTIGATOR
References: