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

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ClinicalTrials.gov Identifier: NCT01818076
Recruitment Status : Terminated (Sponsor decision to terminate study (not due to safety reasons))
First Posted : March 26, 2013
Last Update Posted : May 7, 2014
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Skin Aging Drug: Botulinum Toxin Type A Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2013
Primary Completion Date : July 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT01818076

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

Responsible Party: Revance Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01818076     History of Changes
Other Study ID Numbers: RT001-CL023
First Posted: March 26, 2013    Key Record Dates
Last Update Posted: May 7, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
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