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

Phase 3

Terminated

• Conditions: Skin Aging
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT01818076
• Lead Sponsor: Revance Therapeutics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-26
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Disposition First Submitted: 2013-12-18
• Disposition First Submitted QC: 2013-12-18
• Disposition First Posted: 2014-01-24
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 311

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose A	Botulinum Toxin Type A	Dose A: Botulinum toxin type A

Primary Outcome Measures

Name	Time	Method
Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments	Up to 24 months
Incidences of treatment-emergent laboratory, skin erythema, cranial nerve, and ocular irritation abnormalities when the drug product is administered in repeated treatments	Up to 24 months

Trial Locations

Locations (1)

Nashville Centre for Laser and Facial Surgery; 🇺🇸 Nashville, Tennessee, United States