Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines

This study has been terminated.
(Sponsor decision to terminate study (not due to safety reasons))
Sponsor:
Information provided by (Responsible Party):
Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT01818076
First received: March 20, 2013
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.


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

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]
  • Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments [ Time Frame: Up to 24 months ] [ Designated as safety issue: Yes ]

Enrollment: 312
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose A
Dose A: Botulinum toxin type A
Drug: Botulinum Toxin Type A
Botulinum toxin type A, Dose A applied to the lateral canthal area

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe crow's feet lines
  • Female or male, 18 years of age and above and in good general health
  • Women of childbearing potential 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 3 months
  • Chemical peel during the 9 months prior to treatment
  • Use of prescription retinoid products during the 3 months prior to treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01818076

Locations
United States, Tennessee
Nashville Centre for Laser and Facial Surgery
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Revance Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01818076     History of Changes
Other Study ID Numbers: RT001-CL023
Study First Received: March 20, 2013
Last Updated: December 18, 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 April 17, 2014