Treatment of Moderate to Severe Lateral Canthal Lines and Glabellar Lines Alone or in Combination

Glabellar Frown Lines (GL) 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 Lateral Canthal Lines and Glabellar Lines Alone or in Combination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247074
• Other study ID #: 43QM1902
• Status: Completed
• Phase: Phase 3
• Start date: February 10, 2020
• Est. completion date: February 26, 2021

Study information

• Verified date: June 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 413
• Est. completion date: February 26, 2021
• Est. primary completion date: October 2, 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 LCL at maximum smile as assessed by the Investigator.

3. Moderate to severe LCL at maximum smile as assessed by the subject.

4. Moderate to severe GL at maximum frown as assessed by the Investigator.

5. 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).

Related Conditions & MeSH terms

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

Intervention

Biological:
• botulinum toxin neuromodulator
QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
• Placebo
Placebo will be injected into either the LCL, GL, or both the LCL and GL

Locations

Country	Name	City	State
Canada	Bertucci Medspa, Inc	Woodbridge	Ontario
United States	The Westlake Dermatology Clinical Research	Austin	Texas
United States	Center for Clinical and Cosmetic Research	Aventura	Florida
United States	Washington Institute of Dermatologic Laser Surgery	Chevy Chase	Maryland
United States	Elite Aesthetic Research	Cincinnati	Ohio
United States	Clinical Testing of Beverly Hills	Encino	California
United States	Maryland Dermatology, Laser, Skin & Vein Institute	Hunt Valley	Maryland
United States	Baumann Cosmetic & Research Institute, Inc	Miami	Florida
United States	Lorenc Aesthetic Plastic Surgery Center	New York	New York
United States	Skin Specialists, PC	Omaha	Nebraska
United States	Ava MD	Santa Monica	California
United States	Skin Care & Laser Physicians of Beverly Hills	West Hollywood	California

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	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
Primary	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	Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown		Month 1
Secondary	Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.		Month 1