Status:

TERMINATED

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

Lead Sponsor:

Revance Therapeutics, Inc.

Conditions:

Skin Aging

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2013

Estimated Enrollment :

311 Patients enrolled

Trial Details

Trial ID

NCT01818076

Start Date

February 1 2013

End Date

December 1 2013

Last Update

May 7 2014

Active Locations (1)

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Page 1 of 1 (1 locations)

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Nashville Centre for Laser and Facial Surgery

Nashville, Tennessee, United States, 37203

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