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The Treatment of Glabellar Frown Lines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02096081
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : March 16, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

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).

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: IncobotulinumtoxinA Drug: OnabotulinumtoxinA Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: IncobotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Drug: IncobotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
Other Names:
  • Xeomin®
  • NT201
  • Botulinum toxin type A [150 kDa], free from complexing proteins

Active Comparator: OnabotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points
Drug: OnabotulinumtoxinA
20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
Other Name: Botox®




Primary Outcome Measures :
  1. Efficacy, Measured as the Percentage of Participants Who Responded to Treatment [ Time Frame: 1 Month from baseline ]
    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.


Secondary Outcome Measures :
  1. Response at Maximum Frown Rated by Independent Rater [ Time Frame: 2 months from baseline ]
    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. Response at Maximum Frown Rated by Independent Rater [ Time Frame: 3 months from baseline ]
    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. Response at Maximum Frown Rated by Independent Rater [ Time Frame: 4 months from baseline ]
    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. Response at Maximum Frown Rated by Treating Physician [ Time Frame: 1 month from baseline ]
    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.

  5. Response at Maximum Frown Rated by Treating Physician [ Time Frame: 2 months from baseline ]
    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.

  6. Response at Maximum Frown Rated by Treating Physician [ Time Frame: 3 months from baseline ]
    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.

  7. Response at Maximum Frown Rated by Treating Physician [ Time Frame: 4 months from baseline ]
    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.

  8. Subject Satisfaction [ Time Frame: 1 month from baseline ]
    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."

  9. Subject Satisfaction [ Time Frame: 2 months from baseline ]
    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."

  10. Subject Satisfaction [ Time Frame: 3 months from baseline ]
    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."

  11. Subject Satisfaction [ Time Frame: 4 months from baseline ]
    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."

  12. Subject Perception of Treatment Onset [ Time Frame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary. ]
    Assessment of subject perception of date of treatment onset using a take-home diary

  13. Subject Perception of Treatment Peak Effect [ Time Frame: Open-ended time frame for the 4 month study duration. Data for onset and peak effect is recorded in the subject diary. ]
    Assessment of subject perception of date of treatment peak effect using a take-home diary



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096081


Locations
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United States, California
Merz Investigative Site #001099
Los Angeles, California, United States, 90069
Merz Investigative Site #001300
Sacramento, California, United States, 95819
Merz Investigative Site #001299
Santa Monica, California, United States, 90404
United States, District of Columbia
Merz Investigative Site #001298
Washington, D.C., District of Columbia, United States, 20005
Merz Investigative Site #001170
Washington, D.C., District of Columbia, United States, 20037
United States, Florida
Merz Investigative Site #001101
Coral Gables, Florida, United States, 33146
United States, Louisiana
Merz Investigative Site #001105
Metairie, Louisiana, United States, 70006
United States, Massachusetts
Merz Investigative Site #001098
Chestnut Hill, Massachusetts, United States, 02467
United States, New York
Merz Investigative Site #001297
New York, New York, United States, 10065
United States, Tennessee
Merz Investigative Site #001097
Nashville, Tennessee, United States, 37215
Sponsors and Collaborators
Merz North America, Inc.
Investigators
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Study Director: Andrea Schlӧbe, MD Merz North America, Inc.

Publications of Results:
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Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT02096081     History of Changes
Other Study ID Numbers: MUS 60201_4096_1
First Posted: March 26, 2014    Key Record Dates
Results First Posted: March 16, 2017
Last Update Posted: October 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Merz North America, Inc.:
Glabellar Frown Lines
Frown Lines
Facial Wrinkles

Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents