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

Revance Therapeutics, Inc.1 site in 1 country311 target enrollmentFebruary 2013

ConditionsSkin Aging

InterventionsBotulinum Toxin Type A

DrugsBotulinum Toxin Type A

Overview

Phase: Phase 3
Intervention: Botulinum Toxin Type A
Conditions: Skin Aging
Sponsor: Revance Therapeutics, Inc.
Enrollment: 311
Locations: 1
Primary Endpoint: Incidences of treatment-emergent adverse events and serious treatment-emergent adverse events when the drug product is administered in repeated treatments
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

December 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Revance Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Dose A

Dose A: Botulinum toxin type A

Intervention: Botulinum Toxin Type A

Outcomes

Primary Outcomes

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

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