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Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

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ClinicalTrials.gov Identifier: NCT02236312
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Brief Summary:
The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Drug: Botulinum Toxin Type A Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 359 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Experimental: Botulinum Toxin 30 units
I.M. injection
Drug: Botulinum Toxin Type A
Experimental: Botulinum Toxin 45 units
I.M. injection
Drug: Botulinum Toxin Type A
Experimental: Botulinum Toxin 60 units
I.M. injection
Drug: Botulinum Toxin Type A
Placebo Comparator: Placebo
I.M. injection
Drug: Placebo



Primary Outcome Measures :
  1. Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin [ Time Frame: 14 Days ]
    Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest

Exclusion Criteria:

  • Any previous treatment with any botulinum toxin
  • Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
  • Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
  • Any history of facial surgery above the lower orbital rim
  • Any planned facial surgery or aesthetic procedure during the study period
  • Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period

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): NCT02236312


Locations
United States, Alabama
Private practice
Brimingham, Alabama, United States
Private practice
Mobile, Alabama, United States
United States, California
Private practice
San Diego, California, United States
United States, Colorado
Private practice
Englewood, Colorado, United States
United States, Florida
Private practice
Aventura, Florida, United States
United States, Tennessee
Private practice
Nashville, Tennessee, United States
United States, Texas
Private practice
San Antonio, Texas, United States
United States, Utah
Private practice
Salt Lake City, Utah, United States
Sponsors and Collaborators
Q-Med AB

Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT02236312     History of Changes
Other Study ID Numbers: 43QM1313
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
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