Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines

Allergan

Status and phase: Completed; Phase 4

Conditions: Skin Aging

Treatments: Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856414

MA-BTX-0806

Details and patient eligibility

About

This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)

Enrollment: 45 patients

Sex: Female

Ages: 35 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female subjects of any race, 35-55 years of age
• Moderate to severe glabellar wrinkles (lines between the eyebrows)

Exclusion criteria

• Previous botulinum toxin therapy
• Subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
• Subjects planning a facial cosmetic procedure or visible scars
• Previous cosmetic surgery to the upper face
• Medical condition that may increase their risk of exposure to botulinum toxin including diagnosed Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function
• History of facial nerve palsy
• Allergy or sensitivity to any component of the study medication

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

1

Experimental group

Description:

botulinum toxin Type A 20U

Treatment:

Biological: botulinum toxin Type A