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

Allergan

Status and phase: Completed; Phase 3

Conditions: Lateral Canthus Rhytides; Crow's Feet Lines

Treatments: Biological: onabotulinumtoxinA; Drug: normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01189747

191622-098

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 (Lateral Canthal Rhytides).

Enrollment: 446 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Current or previous botulinum toxin treatment of any serotype
• Facial laser or light treatment, microdermabrasion or superficial peels within 3 months
• Oral retinoid therapy within 1 year
• Prior facial cosmetic surgery (eg, periorbital surgery, facial lift, brow lift, eye lift, or eyebrow surgery)
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

446 participants in 2 patient groups, including a placebo group

onabotulinumtoxinA

Experimental group

Description:

24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.

Treatment:

Biological: onabotulinumtoxinA

placebo (normal saline)

Placebo Comparator group

Description:

normal saline injected into bilateral Crow's Feet Line areas on Day 1.

Treatment:

Drug: normal saline