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Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines (RADIANT)

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ClinicalTrials.gov Identifier: NCT01776606
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : May 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.

Condition or disease Intervention/treatment Phase
Skin Aging Drug: Botulinum Toxin Type A Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2012
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Dose A
Dose A: Botulinum toxin type A
Drug: Botulinum Toxin Type A
Botulinum Toxin Type A, Dose A; dose applied to the lateral canthal lines
Placebo Comparator: Dose B
Dose B: Placebo
Drug: Placebo
Placebo, Dose B; dose applied to the lateral canthal lines


Outcome Measures

Primary Outcome Measures :
  1. Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines [ Time Frame: Week 4 ]

Secondary Outcome Measures :
  1. Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment [ Time Frame: Week 4 ]
  2. Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment [ Time Frame: Week 4 ]
  3. Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment [ Time Frame: Week 4 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe crow's feet lines
  • Female or male, 18 to 65 years of age and in good general health
  • Women of childbearing potential (WOCBP) must agree to use an effective method of birth control during the course of the study

Exclusion Criteria:

  • Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A
  • Muscle weakness or paralysis, particularly in the area receiving study treatment
  • Active skin disease or irritation at the treatment area
  • Deep dermal scarring, or inability to smooth out the crow's feet lines to be treated by manually spreading the skin apart
  • Treatment with botulinum toxin type A for crow's feet lines in the last 6 months
Contacts and Locations

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): NCT01776606


Locations
United States, Florida
Dermatology Research Institute
Coral Gables, Florida, United States, 33146
Sponsors and Collaborators
Revance Therapeutics, Inc.
More Information

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01776606     History of Changes
Other Study ID Numbers: RT001-CL019
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: April 2014

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