Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Crow's Feet Lines and Frown Lines

Allergan

Status and phase: Completed; Phase 3

Conditions: Glabellar Lines; Facial Rhytides; Crow's Feet Lines

Treatments: Biological: onabotulinumtoxinA 44 U; Biological: onabotulinumtoxinA 24 U; Drug: normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189760

191622-099

Details and patient eligibility

About

This study will evaluate the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of Crow's Feet Lines and Frown Lines (Facial Rhytides)

Enrollment: 917 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe Crow's Feet Lines and Frown Lines
• Have adequate vision without the use of eyeglasses to assess facial wrinkles in the mirror (contact lenses OK)

Exclusion criteria

• Current or previous botulinum toxin treatment of any serotype
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
• Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery)
• Facial laser or light treatment, microdermabrasion, or superficial peels within 3 months
• Oral retinoid therapy within one year

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

917 participants in 3 patient groups, including a placebo group

onabotulinumtoxinA 44U

Experimental group

Description:

44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Treatment:

Biological: onabotulinumtoxinA 44 U

onabotulinumtoxinA 24U

Other group

Description:

24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Treatment:

Drug: normal saline

Biological: onabotulinumtoxinA 24 U

placebo (normal saline)

Placebo Comparator group

Description:

Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.

Treatment:

Drug: normal saline