A Study of Subject Satisfaction With BOTOX® Cosmetic Treatment in Facial Rhytides

Allergan

Status and phase: Completed; Phase 4

Conditions: Facial Rhytides

Treatments: Biological: onabotulinumtoxinA; Drug: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01777620

GMA-BTXC-12-001

Details and patient eligibility

About

This is a safety and efficacy study of BOTOX® in subjects with facial rhytides (glabellar lines and crow's feet lines).

Enrollment: 125 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glabellar lines and crow's feet lines
• No prior use of botulinum toxin therapy of any serotype for any reason

Exclusion criteria

• Previous facial cosmetic surgery, tissue grafting, or tissue augmentation with silicone or fat or other permanent fillers
• Planning a facial cosmetic procedure during the study period
• Diagnosis of myasthenia gravis, Eaton-Lambert Syndrome, and/or amyotrophic lateral sclerosis
• Anticipated need for treatment with botulinum toxin of any serotype for any reason during the study (other than study treatment)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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125 participants in 2 patient groups, including a placebo group

BOTOX®

Active Comparator group

Description:

BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Treatment:

Biological: onabotulinumtoxinA

Placebo

Placebo Comparator group

Description:

Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.

Treatment:

Drug: Normal Saline