Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

August 24, 2022 updated by: Galderma R&D

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

301

Phase

  • Phase 3

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
      • Redondo Beach, California, United States, 90277
        • Galderma Study Site
      • San Diego, California, United States, 92121
        • Galderma Study Site
    • Connecticut
      • Westport, Connecticut, United States, 06877
        • Galderma Study Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Galderma Study Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Galderma Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Galderma Study Site
    • Missouri
      • Saint Louis, Missouri, United States, 63103
        • Galderma Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Galderma Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Galderma Study Site
    • Texas
      • Austin, Texas, United States, 78746
        • Galderma Study Site
      • Spring, Texas, United States, 77388
        • Galderma Study 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe glabellar lines at maximum frown
  • Understands the study requirements and signs an informed consent form

Exclusion Criteria:

  • Botulinum toxin treatment in the face within 6 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: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Other: Placebo
Treatment of glabellar facial lines with placebo
EXPERIMENTAL: Experimental
AbobotulinumtoxinA
Biological: AbobotulinumtoxinA
Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo
Time Frame: Month 1 after treatment
Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)
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)

June 17, 2019

Primary Completion (ACTUAL)

September 27, 2019

Study Completion (ACTUAL)

April 16, 2020

Study Registration Dates

First Submitted

May 21, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (ACTUAL)

May 23, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43USD1805

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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