Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines

August 24, 2022 updated by: Galderma R&D

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

An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

401

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
      • Encino, California, United States, 91436
        • Galderma Research Site
      • Manhattan Beach, California, United States, 90266
        • Galderma Research Site
      • Vista, California, United States, 92083
        • Galderma Research Site
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Galderma Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Galderma Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70130
        • Galderma Research Site
    • New York
      • New York, New York, United States, 10028
        • Galderma Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Galderma Research Site
      • Charlotte, North Carolina, United States, 28207
        • Galderma Research Site
    • Wisconsin
      • Mequon, Wisconsin, United States, 53092
        • 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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale
  • Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale

Exclusion Criteria:

  • Botulinum toxin treatment in the face within 9 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Intramuscular single treatment
Other: placebo
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
EXPERIMENTAL: AbobotulinumtoxinA dose level 1 or 2
Intramuscular single treatment
Biological: AbobotulinumtoxinA dose level 1 or 2
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
EXPERIMENTAL: AbobotulinumtoxinA dose level 3
Intramuscular single treatment
Biological: AbobotulinumtoxinA dose 3
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
EXPERIMENTAL: AbobotulinumtoxinA dose level 4
Intramuscular single treatment
Biological: AbobotulinumtoxinA dose 4
Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Composite Responders at Month 1
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 grade 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)

November 26, 2018

Primary Completion (ACTUAL)

December 9, 2019

Study Completion (ACTUAL)

August 20, 2020

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (ACTUAL)

November 9, 2018

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

  • 43USD1801

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

product manufactured in and exported from the U.S.

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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