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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01776606
First received: January 18, 2013
Last updated: April 14, 2014
Last verified: April 2014
  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:


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 ]

Enrollment: 247
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776606

Locations
United States, Florida
Dermatology Research Institute
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 14, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014