Assess Aesthetic Improvement With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

March 25, 2024 updated by: Galderma R&D

Open-label Study to Assess Aesthetic Improvement Following Treatment With QM1114-DP in Subjects With Moderate to Severe Lateral Canthal Lines and Glabellar Lines

This study to assess aesthetic improvement following treatment with QM1114-DP.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, single-center multi-center study to assess aesthetic improvement in the Glabellar and Lateral Canthal regions following treatment with QM1114-DP.

Study Type

Interventional

Enrollment (Actual)

25

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 Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • 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 bilaterally symmetrical LCL as assessed by the investigator
  • Moderate to severe GL at maximum frown as assessed by the Investigator

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.
  • Known allergy to hypersensitivity or any component of the Investigational product

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: QM1114-DP
Biological: QM1114-DP
QM1114-DP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1
Time Frame: 1 month
Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum frown
1 month
Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum smile at Month 1
Time Frame: 1 month
Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum smile
1 month

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)

January 23, 2023

Primary Completion (Actual)

March 31, 2023

Study Completion (Actual)

June 23, 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)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 43QM2107

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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