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OpenTrials
Completed

NCT Number: NCT04080882

Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

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

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Key information

Conditions

Platysmal Bands

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Galderma Research Site, Encinitas, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AbobotulinumtoxinA dose 1

Biological

Treatment of platysmal bands

Placebo

Other

Treatment of platysmal bands

AbobotulinumtoxinA dose 2

Biological

Treatment of platysmal bands

AbobotulinumtoxinA dose 3

Biological

Treatment of platysmal bands

Primary outcomes

  1. Responder Rate at Month 1 for a Single Dose of abobotulinumtoxinA Compared to Placebo

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Multicenter, Randomized, Dose-Ranging, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Moderate to Severe Platysmal Bands

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 6, 2019
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.