Long-term Treatment of Moderate to Severe Glabellar Lines and Lateral Canthal Lines

NCT ID: NCT04225260

Last Updated: 2023-06-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

902 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-27

Study Completion Date

2021-05-21

Brief Summary

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This is a phase 3, multicenter, open-label study to evaluate the safety of QM1114-DP for the long term treatment of moderate to severe Glabellar (Frown) Lines (GL) and Lateral Canthal Lines (Crow's Feet and LCL).

Detailed Description

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Conditions

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Glabellar Lines Lateral Canthal Lines

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QM1114-DP in the LCL and the GL areas

The investigational product (QM1114-DP) is a BoNT Type A.

At each treatment a total dose of QM1114-DP will be administered in the glabella and lateral canthal lines.

Group Type EXPERIMENTAL

botulinum toxin neuromodulator

Intervention Type BIOLOGICAL

A dose of QM1114-DP will be injected in the GL area and in the LCL area.

Interventions

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botulinum toxin neuromodulator

A dose of QM1114-DP will be injected in the GL area and in the LCL area.

Intervention Type BIOLOGICAL

Other Intervention Names

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QM1114-DP

Eligibility Criteria

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Inclusion Criteria

\- Male or female at least 18 years of age.

Exclusion Criteria

* Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
* Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than the investigational product).
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Total Skin and Beauty Dermatology Center, PC

Birmingham, Alabama, United States

Site Status

Investigate MD, LLC.

Scottsdale, Arizona, United States

Site Status

Center for Dermatology Clinical Research, Inc.

Fremont, California, United States

Site Status

Rejuva Medical Aesthetics, LLC

Los Angeles, California, United States

Site Status

Westside Aesthetics

Los Angeles, California, United States

Site Status

Marcus Facial Plastic Surgery

Redondo Beach, California, United States

Site Status

The Maas Clinic Research Center

San Francisco, California, United States

Site Status

ArteMedica

Santa Rosa, California, United States

Site Status

AboutSkin Research, LLC

Greenwood Village, Colorado, United States

Site Status

Modern Dermatology PC

Westport, Connecticut, United States

Site Status

Center for Clinical and Cosmetic Research

Aventura, Florida, United States

Site Status

Steven Fagien, MD, PA

Boca Raton, Florida, United States

Site Status

Susan H. Weinkle, M.D

Bradenton, Florida, United States

Site Status

Miami Skin and Vein LLC

Coral Gables, Florida, United States

Site Status

Mayoral Dermatology

Coral Gables, Florida, United States

Site Status

Skin Research Institute, LLC

Coral Gables, Florida, United States

Site Status

Research Institute of SouthEast, LLC

West Palm Beach, Florida, United States

Site Status

Hamilton Research LLC

Alpharetta, Georgia, United States

Site Status

Chicago Cosmetic Surgery and Dermatology, Inc

Chicago, Illinois, United States

Site Status

Pure Dermatology, LLC

Metairie, Louisiana, United States

Site Status

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Skin Laser and Surgery Specialist of NY/NJ

Hackensack, New Jersey, United States

Site Status

Elite Aesthetic Research

Cincinnati, Ohio, United States

Site Status

Aventiv Research, Inc.

Dublin, Ohio, United States

Site Status

Dallas Plastic Surgery Institute

Dallas, Texas, United States

Site Status

Center for Advanced Clinical Research

Dallas, Texas, United States

Site Status

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, United States

Site Status

SkinDC, PLLC

Arlington, Virginia, United States

Site Status

EthiQ2 Research, LLC

Mequon, Wisconsin, United States

Site Status

Jose Raul Montes Eyes & Facial Rejuvenation LLC

San Juan, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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43QM1903

Identifier Type: -

Identifier Source: org_study_id

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