Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines

Revance Therapeutics

Status and phase: Completed; Phase 2

Conditions: Glabellar Frown Lines

Treatments: Biological: Active Comparator botulinum toxin; Biological: Placebo Comparator; Biological: Botulinum Toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02303002

File No. 9427-R1312\1-22C (Other Identifier)

CTA Control No. 179120 (Other Identifier)

RT002-CL002

Details and patient eligibility

About

This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.

Enrollment: 268 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate or severe glabellar frown lines
• Female or male, 30 to 65 years of age in good general health
• Women of childbearing potential must agree to use an effective method of birth control during the course of the study
• Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

Exclusion criteria

• Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
• Muscle weakness or paralysis, particularly in the treatment area
• Active skin disease or infections or irritation at the treatment area
• Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
• Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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268 participants in 5 patient groups, including a placebo group

Dose A

Experimental group

Description:

Dose A: Botulinum Toxin Type A

Treatment:

Biological: Botulinum Toxin Type A

Dose B

Experimental group

Description:

Dose B: Botulinum Toxin Type A

Treatment:

Biological: Botulinum Toxin Type A

Dose C

Experimental group

Description:

Dose C: Botulinum Toxin Type A

Treatment:

Biological: Botulinum Toxin Type A

Dose D

Active Comparator group

Description:

Dose D: Botulinum Toxin Type A

Treatment:

Biological: Active Comparator botulinum toxin

Dose E

Placebo Comparator group

Description:

Dose E: Placebo

Treatment:

Biological: Placebo Comparator