Treatment of Moderate to Severe Lateral Canthal Lines

Lateral Canthal 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 Lateral Canthal Lines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04249687
• Other study ID #: 43QM1901
• Status: Completed
• Phase: Phase 3
• Start date: February 10, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: March 2021
• 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 LCL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: February 10, 2021
• Est. primary completion date: September 25, 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.

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.

Related Conditions & MeSH terms

• Lateral Canthal Lines

Intervention

Biological:
• botulinum toxin
neuromodulator
• Placebo
placebo

Locations

Country	Name	City	State
Canada	Dr. Shannon Humphrey, Inc	Vancouver	British Columbia
Canada	Pacific Dermaesthetics, Inc	Vancouver	British Columbia
United States	Facial Plastic Surgicenter, Ltd	Baltimore	Maryland
United States	Siperstein Dermatology Group, PLLC	Boynton Beach	Florida
United States	Aesthetic Solutions, PA	Chapel Hill	North Carolina
United States	Ablon Skin Institute and Research Center	Manhattan Beach	California
United States	The Center for Dermatology, Cosmetic & Laser Surgery	Mount Kisco	New York
United States	Dermatology Cosmetic Laser Medical Associates	San Diego	California
United States	Art of Skin, MD	Solana Beach	California
United States	Rochester Dermatologic Surgery, Ltd	Victor	New York

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 Lateral Canthal Line Investigator and Subject Assessments at Maximum Smile at One Month.	The investigator and subject evaluate the subject's LCL severity using a 4-grade scale (0 = none and 3 = severe)	Month 1
Secondary	Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.		One Month