Safety and Efficacy Study of Botulinum Toxin for the Treatment of Glabellar Frown Lines

August 24, 2022 updated by: Galderma R&D

A Multicentre, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Three Doses of Botulinum Toxin in the Treatment of Moderate to Very Severe Glabellar Frown Lines

The primary objective of the study is to evaluate the efficacy in wrinkle reduction of a single treatment of three different doses of botulinum toxin compared to placebo, in the treatment of moderate to very severe glabellar frown lines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

359

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
    • Alabama
      • Birmingham, Alabama, United States
        • Private Practice
      • Mobile, Alabama, United States
        • Private Practice
    • California
      • San Diego, California, United States
        • Private Practice
    • Colorado
      • Englewood, Colorado, United States
        • Private Practice
    • Florida
      • Aventura, Florida, United States
        • Private Practice
    • Tennessee
      • Nashville, Tennessee, United States
        • Private Practice
    • Texas
      • San Antonio, Texas, United States
        • Private Practice
    • Utah
      • Salt Lake City, Utah, United States
        • Private Practice

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to Very Severe glabellar lines at maximum frown as assessed by the subject and the Investigator and at least Mild glabellar lines at rest

Exclusion Criteria:

  • Any previous treatment with any botulinum toxin
  • Rhytids of the glabellar region that cannot be smoothed out by manually spreading the skin apart
  • Any previous insertion of any permanent or semi-permanent material, hyaluronic acid or collagen fillers to the glabellar region
  • Any history of facial surgery above the lower orbital rim
  • Any planned facial surgery or aesthetic procedure during the study period
  • Ablative skin resurfacing or chemical peels above the lower orbital rim in the previous 12 months or during the study period

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Botulinum Toxin 30 units
I.M. injection
Drug: Botulinum Toxin Type A
Experimental: Botulinum Toxin 45 units
I.M. injection
Drug: Botulinum Toxin Type A
Experimental: Botulinum Toxin 60 units
I.M. injection
Drug: Botulinum Toxin Type A
Placebo Comparator: Placebo
I.M. injection
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of glabellar frown line severity on Day 14 following treatment with botulinum toxin
Time Frame: 14 Days
Reduction in glabellar frown line severity is derived separately for the Investigator and the subject assessment, using a validated photo scale, at maximum frown on Day 14.
14 Days

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

September 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

September 1, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43QM1313

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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