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The Treatment of Glabellar Frown Lines

NCT ID: NCT02096081

Last Updated: 2017-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Glabellar Frown Lines

Keywords

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Glabellar Frown Lines Frown Lines Facial Wrinkles

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IncobotulinumtoxinA

20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points

Group Type EXPERIMENTAL

IncobotulinumtoxinA

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

OnabotulinumtoxinA

Intervention Type DRUG

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

Interventions

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IncobotulinumtoxinA

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

Intervention Type DRUG

OnabotulinumtoxinA

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

Intervention Type DRUG

Other Intervention Names

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Xeomin® NT201 Botulinum toxin type A [150 kDa], free from complexing proteins Botox®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merz North America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Schlӧbe, MD

Role: STUDY_DIRECTOR

Merz North America, Inc.

Locations

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Merz Investigative Site #001099

Los Angeles, California, United States

Site Status

Merz Investigative Site #001300

Sacramento, California, United States

Site Status

Merz Investigative Site #001299

Santa Monica, California, United States

Site Status

Merz Investigative Site #001298

Washington D.C., District of Columbia, United States

Site Status

Merz Investigative Site #001170

Washington D.C., District of Columbia, United States

Site Status

Merz Investigative Site #001101

Coral Gables, Florida, United States

Site Status

Merz Investigative Site #001105

Metairie, Louisiana, United States

Site Status

Merz Investigative Site #001098

Chestnut Hill, Massachusetts, United States

Site Status

Merz Investigative Site #001297

New York, New York, United States

Site Status

Merz Investigative Site #001097

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 26509943 (View on PubMed)

Other Identifiers

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MUS 60201_4096_1

Identifier Type: -

Identifier Source: org_study_id