Safety of Single and Repeat Treatments of DaxibotulinumtoxinA for Injection for Treatment of Moderate to Severe Glabellar Lines

Revance Therapeutics

Status and phase

Completed

Phase 3

Conditions

Glabellar Frown Lines

Treatments

Biological: Botulinum Toxins, Type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT03004248

1620303

Details and patient eligibility

About

This is a long term safety study of DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines following single and repeat administration.

Enrollment

2,691 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Provide written informed consent including authorization to release health information
Moderate (2) or severe (3) glabellar lines during maximum frown based on the Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale
Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient Frown Wrinkle Severity (PFWS) scale
Willing and able to follow all trial procedures, attend all scheduled visits, and successfully complete the trial

Exclusion criteria

Any neurological condition that may place the subject at increased risk with exposure to botulinum toxin type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
Active skin disease, infections or inflammation at the injection sites
Plan to receive botulinum toxin type A anywhere in the face through the duration of the study
History of allergy or sensitivity to any botulinum toxin preparations or to any component of the test article
Current enrollment in an investigational drug or device trial or participation in such a trial within the last 30 days prior to screening through end of trial