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Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02303002
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.

Brief Summary:
This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.

Condition or disease Intervention/treatment Phase
Glabellar Frown Lines Biological: Botulinum Toxin Type A Biological: Active Comparator botulinum toxin Biological: Placebo Comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 268 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: Dose A
Dose A: Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
Intramuscular injection (IM)

Experimental: Dose B
Dose B: Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
Intramuscular injection (IM)

Experimental: Dose C
Dose C: Botulinum Toxin Type A
Biological: Botulinum Toxin Type A
Intramuscular injection (IM)

Active Comparator: Dose D
Dose D: Botulinum Toxin Type A
Biological: Active Comparator botulinum toxin
IM injection

Placebo Comparator: Dose E
Dose E: Placebo
Biological: Placebo Comparator
IM injection




Primary Outcome Measures :
  1. Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown [ Time Frame: Week 24 ]
  2. Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity [ Time Frame: Up to Week 36 ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate or severe glabellar frown lines
  • Female or male, 30 to 65 years of age in good general health
  • Women of childbearing potential must agree to use an effective method of birth control during the course of the study
  • Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

Exclusion Criteria:

  • Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
  • Muscle weakness or paralysis, particularly in the treatment area
  • Active skin disease or infections or irritation at the treatment area
  • Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
  • Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

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): NCT02303002


Locations
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Canada, British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Revance Therapeutics, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02303002     History of Changes
Other Study ID Numbers: RT002-CL002
CTA Control No. 179120 ( Other Identifier: Health Canada )
File No. 9427-R1312\1-22C ( Other Identifier: Health Canada )
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Botulinum Toxins
Botulinum Toxins, Type A
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