Treatment of Moderate to Severe Glabellar Lines

Galderma R&D300 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 GL.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

300

Conditions

Glabellar Frown Lines

Interventions

botulinum toxinBIOLOGICAL

neuromodulator to be injected in the GL region

PlaceboBIOLOGICAL

Placebo to be injected in the GL area

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 GL at maximum frown as assessed by the Investigator. 3. 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) or any botulinum toxin serotype.

Locations (14)

\Ablon Skin Institute and Research Center

Manhattan Beach, California, United States

Moradi MD

Vista, California, United States

Etre Cosmetic Dermatology and Laser Center

Outcomes

Primary Outcomes

Percentage of Subjects With a ≥ 2-grade Improvement From Baseline on the Glabellar Lines Investigator and Subject Assessments at Maximum Frown at One Month.

The investigator and subject evaluate the subject's GL severity using a 4-grade scale (0 = none and 3 = severe)

Time frame: One Month

Secondary Outcomes

Percentage of Subjects With a 0 or 1 on the Glabellar Lines Investigator Scale at Maximum Frown

Time frame: One Month

Data from ClinicalTrials.gov

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