Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

Galderma

Status and phase: Completed; Phase 2

Conditions: Platysmal Bands

Treatments: Biological: AbobotulinumtoxinA dose 3; Biological: AbobotulinumtoxinA dose 2; Other: Placebo; Biological: AbobotulinumtoxinA dose 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT04080882

43USD1804

Details and patient eligibility

About

Interventional phase 2 study to evaluate safety and efficacy of abobotulinumtoxinA for the treatment of platysmal bands.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Moderate to severe platysmal bands at maximum contraction as assessed by the Investigator using a photographic scale
• Platysmal bands graded as Level 3 or 4 at maximum contraction as assessed by the subject using a photographic scale

Exclusion criteria

• Botulinum toxin treatment of any serotype below the lower orbital rim, in the neck or chest within 12 months prior to study treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

AbobotulinumtoxinA dose 1

Active Comparator group

Description:

AbobotulinumtoxinA dose 1 injected into platysma bands

Treatment:

Biological: AbobotulinumtoxinA dose 1

placebo

Placebo Comparator group

Description:

placebo injected into platysma bands

Treatment:

Other: Placebo

AbobotulinumtoxinA dose 2

Active Comparator group

Description:

AbobotulinumtoxinA dose 2 injected into platysma bands

Treatment:

Biological: AbobotulinumtoxinA dose 2

AbobotulinumtoxinA dose 3

Active Comparator group

Description:

AbobotulinumtoxinA dose 3 injected into platysma bands

Treatment:

Biological: AbobotulinumtoxinA dose 3