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Subject Satisfaction With AbobutulinumtoxinA Treatment (DREAM)

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: NCT03687736
Recruitment Status : Completed
First Posted : September 27, 2018
Results First Posted : March 18, 2020
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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Brief Summary:
An interventional Phase 4 study to assess subject satisfaction with abobotulinumtoxinA treatment.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: AbobotulinumtoxinA Phase 4

Detailed Description:
Following signature of informed consent and the screening process, eligible subjects were treated at the Baseline visit (Day 0) with abobotulinumtoxinA in the glabellar region. Subjects were re-treated at the Month 6 visit.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multicenter, Open-Label, Interventional Study to Evaluate Subject Satisfaction of AbobutulinumtoxinA Treatments in Moderate to Severe Glabellar Lines
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : November 7, 2019
Actual Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Arm Intervention/treatment
AbobotulinumtoxinA
Open-label
 Biological: AbobotulinumtoxinA
AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6


Outcome Measures
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Primary Outcome Measures :
  1. Subject Satisfaction When Treated With abobutulinumtoxinA in Their Glabellar Lines [ Time Frame: 12 months ]
    Percentage of subjects satisfied with the treatment results assessed by satisfaction question at Month 12 visit.


Secondary Outcome Measures :
  1. Subject Satisfaction With Aesthetic Outcome in Treated Area [ Time Frame: Months 1,3,6,7,9 and 12 ]
    based on Subject Satisfaction questionnaire data

  2. Evaluate Subject Satisfaction; Appraisal of Lines - Between Eyebrows [ Time Frame: Months 1,3,6,7,9 and 12 ]
    FACE-Q Appraisal of Lines: Between Eyebrows. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.

  3. Evaluate the Impact of Treatment; Psychological Function [ Time Frame: Months 1,3,6,7,9 and 12 ]
    FACE-Q Psychological Function. Scored questionnaire to assess treatment outcome from subject's perspective. Minimum Rasch-transformed score = 0; Maximum Rasch-transformed score = 100. Higher score = better outcome.

  4. Subject Self-Assessment Using a 4-point Categorical Scale [ Time Frame: Months 1,3,6,7,9 and 12 ]
    Evaluate efficacy using a subject self-assessment scale that measures the severity of glabellar lines at maximum frown

  5. Investigator Live Assessment Using a 4-point Photographic Scale of Glabellar Line Severity [ Time Frame: Months 1,3,6,7,9 and 12 ]
    Evaluate efficacy at visits using a 4-point photographic scale of glabellar line severity, by Investigator Live assessment at maximum frown.

  6. Onset of Treatment Response [ Time Frame: After treatment at Baseline and Month 6, assessed up to 1 week after each treatment visit ]
    Subject perception of treatment response


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Moderate to Severe Glabellar Lines at Maximum Frown
  • Understands study requirements and signs an informed consent

Exclusion Criteria:

  • Known allergy to any component of study product
  • Pregnant or breast feeding or intending to get pregnant during the study
  • Botulinum toxin treatment in the face within 9 months
Contacts and Locations
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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): NCT03687736


Locations
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United States, California
Galderma Study Site
Los Angeles, California, United States, 90025
Galderma Study Site
San Francisco, California, United States, 94115
Galderma Study Site
Santa Monica, California, United States, 90404
United States, Colorado
Galderma Study Site
Greenwood Village, Colorado, United States, 80111
United States, Illinois
Galderma Study Site
Chicago, Illinois, United States, 60654
United States, Nebraska
Galderma Study Site
Omaha, Nebraska, United States, 68144
Sponsors and Collaborators
Q-Med AB
  Study Documents (Full-Text)

Documents provided by Q-Med AB:
Study Protocol  [PDF] August 3, 2018
Statistical Analysis Plan  [PDF] February 4, 2019

More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03687736    
Other Study ID Numbers: 43USD1802
First Posted: September 27, 2018    Key Record Dates
Results First Posted: March 18, 2020
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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abobotulinumtoxinA
Botulinum Toxins, Type A
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