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

Allergan

Status and phase: Completed; Phase 4

Conditions: Glabellar Rhytides

Treatments: Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01814670

AP-BTXC-12-001

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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185 participants in 1 patient group

botulinum toxin Type A

Experimental group

Description:

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

Treatment:

Biological: botulinum toxin Type A