Patient Satisfaction Study of BOTOX® Cosmetic in the Treatment of Moderate to Severe Frown Lines

Allergan

Status and phase: Completed; Phase 4

Conditions: Glabellar Frown Lines

Treatments: Biological: botulinum toxin Type A; Drug: normal saline (placebo)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391312

GMA-BTXC-11-001

Details and patient eligibility

About

This was a pilot study to observe patient satisfaction with BOTOX® Cosmetic treatment in glabellar rhytides (frown lines) using a new treatment satisfaction measure.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe glabellar wrinkles (frown lines)

Exclusion criteria

• Previous treatment with botulinum toxin therapy of any serotype
• Facial non-ablative resurfacing laser or light treatment, microdermabrasion, or superficial peels within 3 months
• Any facial cosmetic procedure with medium depth to deep facial chemical peels (e.g., trichloroacetic acid and phenol), mid-facial or periorbital laser skin resurfacing or permanent make-up within 6 months
• Mid-facial or periorbital treatment with non-permanent soft tissue fillers
• Subjects planning a facial cosmetic procedure or visible scars
• Previous cosmetic surgery to the upper face(e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
• Diagnoses of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis
• History of facial nerve palsy
• A planned extended absence during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

botulinum toxin Type A

Active Comparator group

Description:

Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.

Treatment:

Biological: botulinum toxin Type A

placebo (Normal Saline)

Placebo Comparator group

Description:

Normal Saline (placebo) injected into the glabellar region on Day 0.

Treatment:

Drug: normal saline (placebo)