Treatment of Moderate to Severe Lateral Canthal Lines

Galderma R&D303 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

303

Conditions

Lateral Canthal Lines

Interventions

botulinum toxinBIOLOGICAL

neuromodulator

PlaceboBIOLOGICAL

placebo

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (10)

Ablon Skin Institute and Research Center

Manhattan Beach, California, United States

Dermatology Cosmetic Laser Medical Associates

San Diego, California, United States

Art of Skin, MD

Solana Beach, California, United States

Outcomes

Primary Outcomes

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)

Time frame: Month 1

Secondary Outcomes

Percentage of Subjects Who Achieve Grade 0 or 1 in Lateral Canthal Line Investigator Scale at Maximum Smile.

Time frame: One Month

Data from ClinicalTrials.gov

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