NCT04249687

Brief Summary

The objective of the study is to evaluate the efficacy and safety of a single dose of QM1114-DP compared to placebo for the treatment of moderate to severe LCL.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_3

Geographic Reach
2 countries

10 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
24 days until next milestone

First Posted

Study publicly available on registry

January 31, 2020

Completed
10 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

September 25, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

January 7, 2020

Results QC Date

May 23, 2023

Last Update Submit

May 23, 2023

Conditions

Lateral Canthal Lines

Outcome Measures

Primary Outcomes (1)

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

    The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)

    Month 1

Secondary Outcomes (1)

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

    One Month

Study Arms (2)

Treatment

EXPERIMENTAL

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

Biological: botulinum toxin

Placebo

PLACEBO COMPARATOR

A buffered solution; Mode of administration: intramuscular injection

Biological: Placebo

Interventions

botulinum toxinBIOLOGICAL

neuromodulator

Also known as: QM1114-DP
Treatment
PlaceboBIOLOGICAL

placebo

Placebo

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.

You may not qualify if:

  • Previous use of any Botulinum toxin treatment 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) or any botulinum toxin serotype.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ablon Skin Institute and Research Center

Manhattan Beach, California, 90266, United States

Location

Dermatology Cosmetic Laser Medical Associates

San Diego, California, 92121, United States

Location

Art of Skin, MD

Solana Beach, California, 92075, United States

Location

Siperstein Dermatology Group, PLLC

Boynton Beach, Florida, 33472, United States

Location

Facial Plastic Surgicenter, Ltd

Baltimore, Maryland, 21208, United States

Location

The Center for Dermatology, Cosmetic & Laser Surgery

Mount Kisco, New York, 10549, United States

Location

Rochester Dermatologic Surgery, Ltd

Victor, New York, 14564, United States

Location

Aesthetic Solutions, PA

Chapel Hill, North Carolina, 27517, United States

Location

Dr. Shannon Humphrey, Inc

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pacific Dermaesthetics, Inc

Vancouver, British Columbia, V6H-4E1, Canada

Location

MeSH Terms

Interventions

Botulinum Toxins

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

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 31, 2020

Study Start

February 10, 2020

Primary Completion

September 25, 2020

Study Completion

February 10, 2021

Last Updated

June 18, 2023

Results First Posted

June 18, 2023

Record last verified: 2021-03

Locations

US(8)CA(2)