NCT04247074

Brief Summary

This study is designed to evaluate the safety and efficacy of a single dose of QM1114-DP for the treatment of moderate to severe LCL and moderate to severe GL, alone or in combination.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
413

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_3

Geographic Reach
2 countries

12 active sites

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

January 7, 2020

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 29, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

February 10, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 26, 2021

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 6, 2023

Completed
Last Updated

September 6, 2023

Status Verified

June 1, 2023

Enrollment Period

8 months

First QC Date

January 7, 2020

Results QC Date

May 23, 2023

Last Update Submit

August 9, 2023

Conditions

Glabellar Frown Lines (GL)Lateral Canthal Lines (LCL)

Outcome Measures

Primary Outcomes (2)

  • Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown

    Investigator 4-point Photographic Scale of Glabellar Line Severity represents the severity of GL from none (grade 0), mild (grade 1), moderate (grade 2) to severe (grade 3). Each grade is depicted by an individual photograph and a descriptive text. The Investigators used the 4-point Photographic Scale for direct, live comparison with the subject's face at maximum frown. Subjects made their assessment of glabellar line severity independently of the Investigator's assessment. Subjects were asked to evaluate their GL at maximum frown by grading the GL severity from none (grade 0, smooth skin), mild (grade 1, fairly smooth skin), moderate (grade 2, frown lines) to severe (grade 3, deep frown lines).

    Month 1

  • Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile

    Investigator 4-point Photographic Scale of Lateral Canthal Line represents LCL severities from none (grade 0), mild (grade 1), moderate (grade 2), to severe (grade 3). Each grade is also depicted by an individual photograph and descriptive text. The Investigators used the LCL-ILA for direct, live comparison with the subject's face for grading LCL severity. Left and right LCL were assessed at maximum smile. Subject 4-point Photographic Scale of Lateral Canthal Line Severity represents LCL severities from Level 0, Level 1, Level 2, to Level 3. Each grade is also depicted by an individual photograph and descriptive text. Subjects made their assessments independently of the Investigator's assessment. Subjects evaluated their LCL severity (left and right side separately) at maximum smile.

    Month 1

Secondary Outcomes (2)

  • Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown

    Month 1

  • Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.

    Month 1

Study Arms (4)

QM1114-DP in the LCL + Placebo in the GL

EXPERIMENTAL

QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection

Biological: botulinum toxin neuromodulatorBiological: Placebo

Placebo in the LCL and GL

PLACEBO COMPARATOR

A buffered solution; Mode of administration: intramuscular injection

Biological: Placebo

Placebo in the LCL + QM1114-DP in the GL

EXPERIMENTAL

QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection

Biological: botulinum toxin neuromodulatorBiological: Placebo

QM1114-DP in the LCL + GL

EXPERIMENTAL

QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection

Biological: botulinum toxin neuromodulator

Interventions

botulinum toxin neuromodulatorBIOLOGICAL

QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL

Also known as: QM1114-DP
Placebo in the LCL + QM1114-DP in the GLQM1114-DP in the LCL + GLQM1114-DP in the LCL + Placebo in the GL
PlaceboBIOLOGICAL

Placebo will be injected into either the LCL, GL, or both the LCL and GL

Placebo in the LCL + QM1114-DP in the GLPlacebo in the LCL and GLQM1114-DP in the LCL + Placebo in the GL

Eligibility Criteria

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

You may qualify if:

  • Male or female 18 years of age or older.
  • Moderate to severe LCL at maximum smile as assessed by the Investigator.
  • Moderate to severe LCL at maximum smile as assessed by the subject.
  • Moderate to severe GL at maximum frown as assessed by the Investigator.
  • Moderate to severe GL at maximum frown as assessed by the subject

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 or hypersensitivity to any component of the investigational product (QM1114-DP).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Clinical Testing of Beverly Hills

Encino, California, 91436, United States

Location

Ava MD

Santa Monica, California, 90404, United States

Location

Skin Care & Laser Physicians of Beverly Hills

West Hollywood, California, 90069, United States

Location

Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Baumann Cosmetic & Research Institute, Inc

Miami, Florida, 33137, United States

Location

Washington Institute of Dermatologic Laser Surgery

Chevy Chase, Maryland, 20815, United States

Location

Maryland Dermatology, Laser, Skin & Vein Institute

Hunt Valley, Maryland, 21030, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Lorenc Aesthetic Plastic Surgery Center

New York, New York, 10028, United States

Location

Elite Aesthetic Research

Cincinnati, Ohio, 45236, United States

Location

The Westlake Dermatology Clinical Research

Austin, Texas, 78746, United States

Location

Bertucci Medspa, Inc

Woodbridge, Ontario, L4L 8E2, Canada

Location

Results Point of Contact

Title
Galderma Research & Development
Organization
Galderma Research & Development
clinical.studies@galderma.com
8179615000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2020

First Posted

January 29, 2020

Study Start

February 10, 2020

Primary Completion

October 2, 2020

Study Completion

February 26, 2021

Last Updated

September 6, 2023

Results First Posted

September 6, 2023

Record last verified: 2023-06

Locations

CA(1)US(11)