Treatment of Moderate to Severe Glabellar Lines

Glabellar Frown Lines Clinical Trial

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Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of QM1114-DP for the Treatment of Moderate to Severe Glabellar Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249583
• Other study ID #: 43QM1602
• Status: Completed
• Phase: Phase 3
• Start date: February 10, 2020
• Est. completion date: January 5, 2021

Study information

• Verified date: September 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 5, 2021
• Est. primary completion date: August 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glabellar Frown Lines

Intervention

Biological:
• botulinum toxin
neuromodulator to be injected in the GL region
• Placebo
Placebo to be injected in the GL area

Locations

Country	Name	City	State
Canada	Sweat Clinics of Canada	Toronto	Ontario
United States	Dallas Center for Dermatology & Aesthetics	Dallas	Texas
United States	Maryland Dermatology, Laser Skin & Vein	Hunt Valley	Maryland
United States	\Ablon Skin Institute and Research Center	Manhattan Beach	California
United States	Tennessee Clinical Research Center	Nashville	Tennessee
United States	The Practice of Brian S Biesman, MD	Nashville	Tennessee
United States	Etre Cosmetic Dermatology and Laser Center	New Orleans	Louisiana
United States	Robert Schwarcz, MD, PC	New York	New York
United States	Sachin M Shridharani, MD	New York	New York
United States	Skin Specialist, PC	Omaha	Nebraska
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Integrated Aesthetics, Inc	Spring	Texas
United States	Moradi MD	Vista	California
United States	Wilmington Dermatology Center, PLLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With a = 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.	The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)	One Month
Secondary	Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown		One Month