Moderate to Severe Glabellar Frown Lines Clinical Trial
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.
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00770029 -
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines No. 2
|
Phase 3 | |
| Completed |
NCT03806933 -
Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines
|
Phase 2 |