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

This study is currently recruiting participants.
Verified April 2013 by Revance Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01776606
First received: January 18, 2013
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Skin Aging
 Drug: Botulinum Toxin Type A
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Revance Therapeutics, Inc.:

Primary Outcome Measures:
  • Composite endpoint based upon the investigator global assessment and patient assessment of severity of lateral canthal lines [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with 2 point or greater improvement from baseline using the Investigator Global Assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with 1 point or greater improvement from baseline using the Investigator Global Assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
  • Proportion of subjects with a 2 point or greater improvement from baseline using the Patient Severity Assessment [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: December 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01776606

Contacts
Contact: Jane Lee, B.S. (510) 552-8707 Jlee@revance.com

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

No publications provided

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01776606     History of Changes
Other Study ID Numbers: RT001-CL019
Study First Received: January 18, 2013
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013