NCT05148000

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

March 27, 2024

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

October 31, 2021

Last Update Submit

March 25, 2024

Conditions

Glabellar Frown LinesCanthal Lines

Outcome Measures

Primary Outcomes (2)

  • Responders in QM1114-DP versus Placebo using the Global Aesthetic Improvement Scale (GAIS) at maximum frown at Month 1

    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

    Responder Rate is defined as a subject who responds at least Improved on the GAIS at maximum smile

    1 month

Study Arms (1)

QM1114-DP

EXPERIMENTAL

QM1114-DP

Biological: QM1114-DP

Interventions

QM1114-DPBIOLOGICAL

QM1114-DP

QM1114-DP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Galderma Research Site

New York, New York, 10021, United States

Location

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Open Label single site study for treatment of GL and LCL with single treatment of QM1114-DP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2021

First Posted

December 7, 2021

Study Start

January 23, 2023

Primary Completion

March 31, 2023

Study Completion

June 23, 2023

Last Updated

March 27, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)