Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Platysmal Bands

August 24, 2022 updated by: Galderma R&D

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • Galderma Research Site
      • Encino, California, United States, 91436
        • Galderma Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Galderma Research Site
      • Miami, Florida, United States, 33137
        • Galderma Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Galderma Research Site
      • New Orleans, Louisiana, United States, 70130
        • Galderma Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Galderma Research Site
    • New York
      • New York, New York, United States, 10028
        • Galderma Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AbobotulinumtoxinA dose 1
AbobotulinumtoxinA dose 1 injected into platysma bands
Biological: AbobotulinumtoxinA dose 1
Treatment of platysmal bands
Placebo Comparator: placebo
placebo injected into platysma bands
Other: Placebo
Treatment of platysmal bands
Active Comparator: AbobotulinumtoxinA dose 2
AbobotulinumtoxinA dose 2 injected into platysma bands
Biological: AbobotulinumtoxinA dose 2
Treatment of platysmal bands
Active Comparator: AbobotulinumtoxinA dose 3
AbobotulinumtoxinA dose 3 injected into platysma bands
Biological: AbobotulinumtoxinA dose 3
Treatment of platysmal bands

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Month 1 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2019

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

June 4, 2020

Study Registration Dates

First Submitted

September 4, 2019

First Submitted That Met QC Criteria

September 4, 2019

First Posted (Actual)

September 6, 2019

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43USD1804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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