Treatment With Botulinum Toxin Type A (BOTOX®) in Chinese Patients With Moderate to Severe Frown Lines

Allergan185 enrolled

Overview

A study to evaluate safety and efficacy of treatment with botulinum toxin Type A (BOTOX®) in Chinese patients with moderate to severe frown lines (Glabellar Rhytides) previously treated with facial laser resurfacing.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

185

Conditions

Glabellar Rhytides

Interventions

botulinum toxin Type ABIOLOGICAL

20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * moderate or severe frown lines * facial laser treatment between 4 to 8 weeks prior to Day 1 Exclusion Criteria: * previous use of botulinum toxin for any indication * diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis * microdermabrasion or superficial peels, permanent make-up to the brow and forehead area within the last 3 months * facial cosmetic procedures within the last 6 Months * treatment to forehead, brow, nose or midface areas with any filler within the last 12 months * use of a new topical skin care product within 1 month of the screening * any prior forehead or periorbital surgery or brow lift * deep dermal scarring, excessively thick sebaceous skin, and/ or loss of skin elasticity * any facial skin infection or unhealed skin lesion * pregnant or breast-feeding

Locations (1)

Unnamed facility

Beijing, China

Outcomes

Primary Outcomes

Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction

The Investigator assessed the severity of the subject's glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Time frame: Day 1, Day 30

Secondary Outcomes

Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction

Time frame: Day 1, Day 14, Day 90, Day 120

Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Maximum Contraction

The subject assessed the severity of his/her glabellar rhytides at maximum contraction using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Time frame: Day 1, Day 14, Day 30, Day 90, Day 120

Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Investigator Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest

The Investigator assessed the severity of the subject's glabellar rhytides at rest using the 4-point Facial Wrinkle Scale: 0=none, 1=mild, 2=moderate or 3=severe. The percentage of subjects with a ≥ 1-grade improvement from Day 1 is reported.

Time frame: Day 1, Day 14, Day 30, Day 90, Day 120

Percentage of Subjects With a ≥ 1-Grade Improvement From Day 1 in the Subject Assessed Facial Wrinkle Scale of Glabellar Rhytides at Rest

Data from ClinicalTrials.gov

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