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Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03960957
Recruitment Status : Not yet recruiting
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Brief Summary:
An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: AbobotulinumtoxinA Other: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Experimental
AbobotulinumtoxinA
Biological: AbobotulinumtoxinA
Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

Placebo Comparator: Placebo Other: Placebo
Treatment of glabellar facial lines with placebo




Primary Outcome Measures :
  1. Evaluate composite responder rate at Month 1 for a single dose of AbobotulinumtoxinA compared to placebo [ Time Frame: Month 1 after treatment ]
    Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)



Information from the National Library of Medicine

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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 the study requirements and signs an informed consent form

Exclusion Criteria:

  • Botulinum toxin treatment in the face within 6 months prior to study treatment

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): NCT03960957


Contacts
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Contact: Sr. Clinical Project Manager 817-961-5655 aestheticclinicaltrials@galderma.com

Locations
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United States, California
Galderma Study Site Not yet recruiting
Redondo Beach, California, United States, 90277
Contact    310-316-1400      
Galderma Study Site Not yet recruiting
San Diego, California, United States, 92121
Contact    858-657-1004      
United States, Connecticut
Galderma Study Site Not yet recruiting
Westport, Connecticut, United States, 06877
Contact    203-635-0770      
United States, District of Columbia
Galderma Study Site Not yet recruiting
Washington, District of Columbia, United States, 20037
Contact    202-810-7700      
United States, Florida
Galderma Study Site Not yet recruiting
Coral Gables, Florida, United States, 33134
Contact    786-352-8440      
Galderma Study Site Not yet recruiting
Coral Gables, Florida, United States, 33134
Contact    305-665-6166      
United States, Georgia
Galderma Study Site Not yet recruiting
Atlanta, Georgia, United States, 30342
Contact    404-992-8213      
United States, Missouri
Galderma Study Site Not yet recruiting
Saint Louis, Missouri, United States, 63103
Contact    314-256-3436      
United States, Nebraska
Galderma Study Site Not yet recruiting
Omaha, Nebraska, United States, 68144
Contact    402-697-6599      
United States, Ohio
Galderma Study Site Not yet recruiting
Cincinnati, Ohio, United States, 45236
Contact    513-891-5438      
United States, Texas
Galderma Study Site Not yet recruiting
Austin, Texas, United States, 78746
Contact    512-615-3180      
Galderma Study Site Not yet recruiting
Spring, Texas, United States, 77388
Contact    281-404-5454      
Sponsors and Collaborators
Q-Med AB

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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03960957     History of Changes
Other Study ID Numbers: 43USD1805
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
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

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