BOTOX® in the Treatment of Crow's Feet Lines in Japan

Allergan

Status and phase: Completed; Phase 3

Conditions: Lateral Canthus Rhytides; Crow's Feet Lines

Treatments: Biological: botulinum toxin Type A (24 U); Biological: botulinum toxin Type A (12 U); Other: Normal Saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797081

191622-114

Details and patient eligibility

About

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) compared to placebo for the treatment of Crow's Feet Lines (Lateral Canthus Rhytides).

Enrollment: 300 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Moderate to severe Crow's Feet Lines

Exclusion criteria

• Current or previous botulinum toxin treatment of any serotype
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis
• Facial laser or light treatment for cosmetic purposes, microdermabrasion, superficial peels, or topical retinoid therapy or hormone cream within 3 months
• Laser treatment or phototherapy of the face for medical purposes, blepharoplasty, brow-lift or related procedure, periorbital permanent make-up, or oral retinoid therapy within one year
• Medium-depth or deep facial peels within 5 years
• Prior facial cosmetic surgery (e.g., prior periorbital surgery, facial lift, periorbital treatment with fillers, implantation or transplantation)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 4 patient groups

Botulinum toxin Type A (24U)

Experimental group

Description:

24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.

Treatment:

Biological: botulinum toxin Type A (24 U)

Botulinum toxin Type A (12U)

Experimental group

Description:

12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.

Treatment:

Biological: botulinum toxin Type A (12 U)

Placebo/Botulinum toxin Type A (24U)

Other group

Description:

Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).

Treatment:

Biological: botulinum toxin Type A (24 U)

Other: Normal Saline

Placebo/Botulinum toxin Type A (12U)

Other group

Description:

Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).

Treatment:

Biological: botulinum toxin Type A (12 U)

Other: Normal Saline