Treatment of Moderate to Severe Lateral Canthal Lines

Phase 3

Completed

• Conditions: Lateral Canthal Lines
• Interventions: Biological: botulinum toxin; Biological: Placebo

• Registration Number: NCT04249687
• 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 LCL.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-29
• Study First Posted: 2020-01-31
• Study Start: 2020-02-10
• Primary Completion: 2020-09-25
• Study Completion: 2021-02-10
• Status Verified: 2021-03
• Disposition First Submitted: 2021-05-26
• Disposition First Submitted QC: 2021-05-26
• Disposition First Posted: 2021-05-28
• 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: 303

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.

Exclusion Criteria

1. Previous use of any Botulinum toxin treatment 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 Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month.	Month 1	The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.	One Month

Trial Locations

Locations (10)

Facial Plastic Surgicenter, Ltd; 🇺🇸 Baltimore, Maryland, United States

Siperstein Dermatology Group, PLLC; 🇺🇸 Boynton Beach, Florida, United States

Dermatology Cosmetic Laser Medical Associates; 🇺🇸 San Diego, California, United States

Dr. Shannon Humphrey, Inc; 🇨🇦 Vancouver, British Columbia, Canada

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

Rochester Dermatologic Surgery, Ltd; 🇺🇸 Victor, New York, United States

Aesthetic Solutions, PA; 🇺🇸 Chapel Hill, North Carolina, United States

Art of Skin, MD; 🇺🇸 Solana Beach, California, United States

The Center for Dermatology, Cosmetic & Laser Surgery; 🇺🇸 Mount Kisco, New York, United States

Pacific Dermaesthetics, Inc; 🇨🇦 Vancouver, British Columbia, Canada