Treatment of Moderate to Severe Glabellar Lines

Phase 3

Completed

• Conditions: Glabellar Frown Lines
• Interventions: Biological: botulinum toxin; Biological: Placebo

• Registration Number: NCT04249583
• Lead Sponsor: Galderma R&D

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 GL.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2020-02-10
• Primary Completion: 2020-08-07
• Study Completion: 2021-01-05
• Disposition First Submitted: 2021-05-26
• Disposition First Submitted QC: 2021-05-26
• Disposition First Posted: 2021-05-28
• Status Verified: 2022-09
• Results First Submitted: 2023-05-23
• Results First Submitted QC: 2023-05-23
• Last Update Submitted: 2023-05-23
• Results First Posted: 2023-06-18
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Male or female 18 years of age or older.
2. Moderate to severe GL at maximum frown as assessed by the Investigator.
3. Moderate to severe GL at maximum frown as assessed by the subject.

Exclusion Criteria

1. Previous use of any Botulinum toxin in facial areas within 9 months prior to study treatment.
2. Female who is pregnant, breast feeding, or intends to conceive a child during the study.
3. Known allergy or hypersensitivity to any component of the investigational product (QM1114-DP) or any botulinum toxin serotype.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	botulinum toxin	QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
Placebo	Placebo	A buffered solution; Mode of administration: intramuscular injection

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.	One Month	The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown	One Month

Trial Locations

Locations (14)

Dallas Center for Dermatology & Aesthetics; 🇺🇸 Dallas, Texas, United States

Integrated Aesthetics, Inc; 🇺🇸 Spring, Texas, United States

Sachin M Shridharani, MD; 🇺🇸 New York, New York, United States

Robert Schwarcz, MD, PC; 🇺🇸 New York, New York, United States

Maryland Dermatology, Laser Skin & Vein; 🇺🇸 Hunt Valley, Maryland, United States

Austin Institute for Clinical Research, Inc.; 🇺🇸 Pflugerville, Texas, United States

Skin Specialist, PC; 🇺🇸 Omaha, Nebraska, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States

Wilmington Dermatology Center, PLLC; 🇺🇸 Wilmington, North Carolina, United States

Etre Cosmetic Dermatology and Laser Center; 🇺🇸 New Orleans, Louisiana, United States

The Practice of Brian S Biesman, MD; 🇺🇸 Nashville, Tennessee, United States

\Ablon Skin Institute and Research Center; 🇺🇸 Manhattan Beach, California, United States

Moradi MD; 🇺🇸 Vista, California, United States

Sweat Clinics of Canada; 🇨🇦 Toronto, Ontario, Canada