A Study Of BOTOX For The Treatment Of Glabellar Lines

GlaxoSmithKline256 enrolled

Overview

This is a Multicenter, double-blind, randomized, placebo-controlled, parallel-group comparative study to confirm the efficacy and safety of BOTOX 20 units single injection for the Chinese patients with glabellar lines. The subjects will receive a single intramuscular treatment consisting of 5 injections of either BOTOX? 20U or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

256

Conditions

Glabellar Lines

Interventions

Botulinum Toxin Type ADRUG

botulinum toxin type A 100 units, human serum albumin 0.5 mg, sodium chloride 0.9 mg

sodium chlorideDRUG

sodium chloride 0.9 mg

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion criteria: * Male and female adult with Glabellar lines of at least moderate severity at maximum frown by investigator's assessment. Exclusion criteria: * Patients with systemic nerve conduction junction disorder or patients with infection or other skin disease/surgery at injection sites will not be eligible. * Patient with severe complications related to heart, kidney, liver disease or respiratory system will not be eligible.

Locations (4)

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Shanghai, China

Outcomes

Primary Outcomes

The investigator's rating of Glabellar line severity at maximum frown

Time frame: Day 30 after injection

Secondary Outcomes

Investigator's rating of Glabellar line severity at rest, subject's global assessment of change in appearance of glabellar lines, the subject's perception of age and safety evaluations.

Time frame: Day 7, 30, 60, 90, 120 after injection

Data from ClinicalTrials.gov

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