Assess Aesthetic Improvement and Onset of QM1114-DP in Subjects With Moderate to Severe Glabellar Lines

October 18, 2024 updated by: Galderma R&D

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects With Moderate to Severe Glabellar Lines

The objective of this study is to evaluate the aesthetic improvement and onset of QM1114-DP treatment for subjects with moderate to severe glabellar lines

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Assess Aesthetic Improvement and Onset of QM1114-DP Treatment Effect in Subjects with Moderate to Severe Glabellar Lines

Study Type

Interventional

Enrollment (Actual)

132

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
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Galderma Research Site
    • California
      • 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
    • Maryland
      • Hunt Valley, Maryland, United States, 21030
        • Galderma Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Galderma Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Galderma Research Site
    • Texas
      • Pflugerville, Texas, United States, 78660
        • Galderma Research Site
      • Spring, Texas, United States, 77388
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male or Female 18 years or older
  • Moderate to severe GL at maximum frown as assessed by the Investigator
  • Moderate to severe GL at maximum frown as assessed by the subject

Exclusion Criteria:

  • Previous use of any botulinum toxin in facial areas within 9 months prior to study treatment
  • Female who is pregnant, breast feeding or intends to conceive a child during the study.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active arm - QM1114-DP
a Botulinum Toxin Type A (BoNT-A)
Biological: QM1114-DP
QM1114-DP
Placebo Comparator: Inactive arm - Placebo
Biological: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) at Month 1
Time Frame: At Month 1
Participant assessment at Month 1 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a participant who responded "improved," "much improved," or "very much improved" on the participant GAIS at maximum frown. Missing data is imputed as no change (non-responder).
At Month 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting Onset of Treatment Effect Using the Diary Card
Time Frame: At Days 0 through 7 post-treatment
Following treatment at baseline, participants were asked to record their assessment of study treatment response in a diary card on Days 0 through 7. They were asked to respond "yes" or "no" to the following question: "Since being injected, have you noticed an improvement in the appearance of your glabellar lines (lines between your eyebrows) when you frown?" Response to treatment effect given by a Participant on first day as "yes" to the diary question.
At Days 0 through 7 post-treatment
Number of Responders Using the Global Aesthetic Improvement Scale (GAIS) From Day 1 Through Month 12
Time Frame: From Day 1 through Month 12
Participant assessment From Day 1 through Month 12 of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale. GAIS is a 7-graded scale: Very much worse; much worse; worse; no change; improved; much improved; or very much improved. A responder was defined as a Participant who responded "improved," "much improved," or "very much improved" on the GAIS at maximum frown. This analysis is based on observed cases.
From Day 1 through Month 12

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)

May 9, 2022

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

October 31, 2021

First Submitted That Met QC Criteria

November 23, 2021

First Posted (Actual)

December 7, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2024

Last Update Submitted That Met QC Criteria

October 18, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 43QM2106

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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