Safety and Efficacy of AbobotulinumtoxinA for the Treatment of Glabellar Lines

Phase 2CompletedNCT03736928

Galderma R&D401 enrolled

Overview

An interventional phase 2 study to evaluate safety and efficacy of AbobotulinumtoxinA treatment for glabellar lines

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

401

Conditions

Glabellar Frown Lines

Interventions

AbobotulinumtoxinA dose level 1 or 2BIOLOGICAL

Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines

placeboOTHER

Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines

AbobotulinumtoxinA dose 3BIOLOGICAL

Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate to severe glabellar lines at maximum frown as assessed by the Investigator using a photographic scale * Moderate to severe glabellar lines at maximum frown as assessed by the subject using a static categorical scale Exclusion Criteria: * Botulinum toxin treatment in the face within 9 months prior to study treatment

Locations (10)

Galderma Research Site

Encino, California, United States

Galderma Research Site

Manhattan Beach, California, United States

Galderma Research Site

Vista, California, United States

Outcomes

Primary Outcomes

Number of Composite Responders at Month 1

composite responder is defined as a subject who achieves a score of 0 or 1 and at least 2 grade 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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