Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

Phase 2

Completed

• Conditions: Platysmal Bands
• Interventions: Biological: AbobotulinumtoxinA dose 1; Biological: AbobotulinumtoxinA dose 3; Biological: AbobotulinumtoxinA dose 2; Other: Placebo

• Registration Number: NCT04080882
• Lead Sponsor: Galderma R&D

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2019-09-25
• Primary Completion: 2019-12-30
• Study Completion: 2020-06-04
• Results First Submitted: 2020-12-28
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-20
• Results First Posted: 2021-01-22
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
AbobotulinumtoxinA dose 1	AbobotulinumtoxinA dose 1	AbobotulinumtoxinA dose 1 injected into platysma bands
AbobotulinumtoxinA dose 3	AbobotulinumtoxinA dose 3	AbobotulinumtoxinA dose 3 injected into platysma bands
AbobotulinumtoxinA dose 2	AbobotulinumtoxinA dose 2	AbobotulinumtoxinA dose 2 injected into platysma bands
placebo	Placebo	placebo injected into platysma bands

Primary Outcome Measures

Name	Time	Method
Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo	Month 1 after treatment	A responder is defined as a subject who achieves grade 1 or 2 in platysmal band severity on the Investigator Live Assessment (ILA).

Trial Locations

Locations (1)

Galderma Research Site; 🇺🇸 New York, New York, United States