The Treatment of Glabellar Frown Lines

Glabellar Frown Lines Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096081
• Other study ID #: MUS 60201_4096_1
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2014
• Last updated: September 18, 2017
• Start date: February 2014
• Est. completion date: November 2014

Study information

• Verified date: September 2017
• Source: Merz Pharmaceuticals, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: November 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Drug:
• IncobotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
• OnabotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection

Locations

Country	Name	City	State
United States	Merz Investigative Site #001098	Chestnut Hill	Massachusetts
United States	Merz Investigative Site #001101	Coral Gables	Florida
United States	Merz Investigative Site #001099	Los Angeles	California
United States	Merz Investigative Site #001105	Metairie	Louisiana
United States	Merz Investigative Site #001097	Nashville	Tennessee
United States	Merz Investigative Site #001297	New York	New York
United States	Merz Investigative Site #001300	Sacramento	California
United States	Merz Investigative Site #001299	Santa Monica	California
United States	Merz Investigative Site #001170	Washington, D.C.	District of Columbia
United States	Merz Investigative Site #001298	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Dermat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy, Measured as the Percentage of Participants Who Responded to Treatment	Response defined as = 1 point improvement from baseline (prior to treatment) on the Facial Wrinkle Scale at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 1 month from treatment.	1 Month from baseline
Secondary	Response at Maximum Frown Rated by Independent Rater	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 2 months from baseline.	2 months from baseline
Secondary	Response at Maximum Frown Rated by Independent Rater	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 3 months from baseline.	3 months from baseline
Secondary	Response at Maximum Frown Rated by Independent Rater	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by an independent masked panel of physicians specifically qualified to assess study photographs using subject photographs at 4 months from baseline.	4 months from baseline
Secondary	Response at Maximum Frown Rated by Treating Physician	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 1 month from treatment.	1 month from baseline
Secondary	Response at Maximum Frown Rated by Treating Physician	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 2 months from treatment.	2 months from baseline
Secondary	Response at Maximum Frown Rated by Treating Physician	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 3 months from treatment.	3 months from baseline
Secondary	Response at Maximum Frown Rated by Treating Physician	Response defined as = 1 point improvement from baseline on the Facial Wrinkle Scale (0=None to 3=severe) at maximum frown as rated by the treating physicians using subject photographs at 4 months from treatment.	4 months from baseline
Secondary	Subject Satisfaction	Assessment of subject treatment satisfaction by subject questionnaire and diary at 1 month from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."	1 month from baseline
Secondary	Subject Satisfaction	Assessment of subject treatment satisfaction by subject questionnaire and diary at 2 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."	2 months from baseline
Secondary	Subject Satisfaction	Assessment of subject treatment satisfaction by subject questionnaire and diary at 3 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."	3 months from baseline
Secondary	Subject Satisfaction	Assessment of subject treatment satisfaction by subject questionnaire and diary at 4 months from treatment. Extremely satisfied, satisfied, and slightly satisfied were categorized as "Satisfaction" and extremely dissatisfied, dissatisfied, and slightly dissatisfied were categorized as "Dissatisfaction." Subjects with missing data were categorized as "Missing."	4 months from baseline
Secondary	Subject Perception of Treatment Onset	Assessment of subject perception of date of treatment onset using a take-home diary	Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.
Secondary	Subject Perception of Treatment Peak Effect	Assessment of subject perception of date of treatment peak effect using a take-home diary	Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary.