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

Phase 3

Completed

• Conditions: Glabellar Frown Lines (GL); Lateral Canthal Lines (LCL)
• Interventions: Biological: Placebo; Biological: botulinum toxin neuromodulator

• Registration Number: NCT04247074
• Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Study Start: 2020-02-10
• Primary Completion: 2020-10-02
• Study Completion: 2021-02-26
• Disposition First Submitted: 2021-05-26
• Results First Submitted: 2023-05-23
• Status Verified: 2023-06
• Results First Submitted QC: 2023-08-09
• Last Update Submitted: 2023-08-09
• Results First Posted: 2023-09-06
• Disposition First Posted: 2023-09-06
• Last Update Posted: 2023-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 413

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo in the LCL and GL	Placebo	A buffered solution; Mode of administration: intramuscular injection
QM1114-DP in the LCL + Placebo in the GL	botulinum toxin neuromodulator	QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
Placebo in the LCL + QM1114-DP in the GL	botulinum toxin neuromodulator	QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection
Placebo in the LCL + QM1114-DP in the GL	Placebo	QM1114-DP, a Botulinum Toxin Type A (BoNT-A) or placebo Mode of administration: intramuscular injection
QM1114-DP in the LCL + Placebo in the GL	Placebo	QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection
QM1114-DP in the LCL + GL	botulinum toxin neuromodulator	QM1114-DP, a Botulinum Toxin Type A (BoNT-A) ; Mode of administration: intramuscular injection

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Lateral Canthal Lines Investigator and Subject Assessments at Maximum Smile	Month 1	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.
Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown	Month 1	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).

Secondary Outcome Measures

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

Trial Locations

Locations (12)

Ava MD; 🇺🇸 Santa Monica, California, United States

Baumann Cosmetic & Research Institute, Inc; 🇺🇸 Miami, Florida, United States

Clinical Testing of Beverly Hills; 🇺🇸 Encino, California, United States

Skin Care & Laser Physicians of Beverly Hills; 🇺🇸 West Hollywood, California, United States

Center for Clinical and Cosmetic Research; 🇺🇸 Aventura, Florida, United States

Washington Institute of Dermatologic Laser Surgery; 🇺🇸 Chevy Chase, Maryland, United States

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

Lorenc Aesthetic Plastic Surgery Center; 🇺🇸 New York, New York, United States

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

Elite Aesthetic Research; 🇺🇸 Cincinnati, Ohio, United States

The Westlake Dermatology Clinical Research; 🇺🇸 Austin, Texas, United States

Bertucci Medspa, Inc; 🇨🇦 Woodbridge, Ontario, Canada