Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Galderma R&D301 enrolled

Overview

An interventional phase 3 study to evaluate efficacy and safety of a new dilution and injection volume of AbobotulinumtoxinA treatment for glabellar lines

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

301

Conditions

Glabellar Frown Lines

Interventions

AbobotulinumtoxinABIOLOGICAL

Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA

PlaceboOTHER

Treatment of glabellar facial lines with placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe glabellar lines at maximum frown * Understands the study requirements and signs an informed consent form Exclusion Criteria: * Botulinum toxin treatment in the face within 6 months prior to study treatment

Locations (11)

Galderma Study Site

Redondo Beach, California, United States

Galderma Study Site

San Diego, California, United States

Galderma Study Site

Westport, Connecticut, United States

Outcomes

Primary Outcomes

Evaluate Composite Responder Rate at Month 1 for a Single Dose of AbobotulinumtoxinA Compared to Placebo

Composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grades improvement on both the Investigator Live Assessment (ILA) and the Subject Self Assessment (SSA)

Time frame: Month 1 after treatment

Data from ClinicalTrials.gov

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