Clinical trial NCT02096081: The Treatment of Glabellar Frown Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glabellar Frown Lines
Keywords: Glabellar Frown Lines
Frown Lines
Facial Wrinkles
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to show that two FDA-approved botulinum toxin drugs called Xeomin® and Botox® can reduce the severity of vertical lines (wrinkles) that appear between the eyebrows (glabellar frown lines).

Detailed description: This is a prospective, multicenter, randomized, double-blind, parallel group clinical study to investigate the equivalence of incobotulinumtoxinA (Xeomin®) to onabotulinumtoxinA (Botox®) in the treatment of glabellar frown lines.

Eligibility criteria: Inclusion Criteria:

* Outpatient females 18 to 50 years of age
* Moderate to severe glabellar frown lines

Exclusion Criteria:

* Glabellar Frown Lines at rest rating 3 on the 4-point Facial Wrinkle Scale
* Previous treatment with botulinum toxin
* Previous treatment with biodegradable fillers in glabellar area within last 12 months
* Any severe or uncontrolled systemic disease, malignant tumor, or medical history of HIV infection
* Known hypersensitivity to incobotulinumtoxinA or onabotulinumtoxinA or to any of their excipients
* Intake of any of the forbidden concomitant medication or other agents that might interfere with neuromuscular function or might interfere with the action of botulinum toxin type within 14 days prior to injection

Primary outcomes:
measure: Efficacy, Measured as the Percentage of Participants Who Responded to Treatment
timeFrame: 1 Month from baseline
Secondary outcomes:
measure: Response at Maximum Frown Rated by Independent Rater
timeFrame: 2 months from baseline
measure: Response at Maximum Frown Rated by Independent Rater
timeFrame: 3 months from baseline
measure: Response at Maximum Frown Rated by Independent Rater
timeFrame: 4 months from baseline
measure: Response at Maximum Frown Rated by Treating Physician
timeFrame: 1 month from baseline
measure: Response at Maximum Frown Rated by Treating Physician
timeFrame: 2 months from baseline
measure: Response at Maximum Frown Rated by Treating Physician
timeFrame: 3 months from baseline
measure: Response at Maximum Frown Rated by Treating Physician
timeFrame: 4 months from baseline
measure: Subject Satisfaction
timeFrame: 1 month from baseline
measure: Subject Satisfaction
timeFrame: 2 months from baseline
measure: Subject Satisfaction
timeFrame: 3 months from baseline
measure: Subject Satisfaction
timeFrame: 4 months from baseline
measure: Subject Perception of Treatment Onset
timeFrame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
measure: Subject Perception of Treatment Peak Effect
timeFrame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Merz Investigative Site #001099
state: California
city: Sacramento
country: United States
facility: Merz Investigative Site #001300
state: California
city: Santa Monica
country: United States
facility: Merz Investigative Site #001299
state: California
city: Washington, D.C.
country: United States
facility: Merz Investigative Site #001298
state: District of Columbia
city: Washington, D.C.
country: United States
facility: Merz Investigative Site #001170
state: District of Columbia
city: Coral Gables
country: United States
facility: Merz Investigative Site #001101
state: Florida
city: Metairie
country: United States
facility: Merz Investigative Site #001105
state: Louisiana
city: Chestnut Hill
country: United States
facility: Merz Investigative Site #001098
state: Massachusetts
city: New York
country: United States
facility: Merz Investigative Site #001297
state: New York
city: Nashville
country: United States
facility: Merz Investigative Site #001097
state: Tennessee
Study officials:
affiliation: Merz North America, Inc.
name: Andrea Schlӧbe, MD
role: STUDY_DIRECTOR
References:
citation: Kane MA, Gold MH, Coleman WP 3rd, Jones DH, Tanghetti EA, Alster TS, Rohrer TE, Burgess CM, Shamban AT, Finn E. A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines. Dermatol Surg. 2015 Nov;41(11):1310-9. doi: 10.1097/DSS.0000000000000531.