Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines

Revance Therapeutics

Status and phase: Completed; Phase 3

Conditions: Glabellar Frown Lines

Treatments: Biological: Placebos; Biological: Botulinum Toxins, Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03014635

1620302

Details and patient eligibility

About

This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to severe frown lines.

Enrollment: 306 patients

Sex: All

Ages: 18 to 75 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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306 participants in 2 patient groups, including a placebo group

DaxibotulinumtoxinA 40 units

Experimental group

Description:

Biological/Vaccine: Botulinum Toxins, Type A Intramuscular injection

Treatment:

Biological: Botulinum Toxins, Type A

Placebo

Placebo Comparator group

Description:

Biological/Vaccine: Placebos Intramuscular injection

Treatment:

Biological: Placebos