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Completed

NCT Number: NCT02096081

The Treatment of Glabellar Frown Lines

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).

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Key information

Conditions

Glabellar Frown Lines

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Merz Investigative Site #001099, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

incobotulinumtoxinA

Drug

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

OnabotulinumtoxinA

Drug

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

Other names: Botox®

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Merz North America, Inc.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 26, 2014
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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