BOTOX® in the Treatment of Upper Facial Lines in Japan

Allergan

Status and phase: Completed; Phase 3

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

Treatments: Biological: botulinum toxin Type A (44U); Biological: botulinum toxin Type A (32U)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797094

191622-122

Details and patient eligibility

About

This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) for the treatment of upper facial lines (Crow's Feet Lines and Frown Lines).

Enrollment: 101 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Moderate to severe Crow's Feet Lines and Frown 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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101 participants in 2 patient groups

Botulinum toxin Type A (44U)

Experimental group

Description:

44 units (U) botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.

Treatment:

Biological: botulinum toxin Type A (44U)

Botulinum toxin Type A (32U)

Experimental group

Description:

32 units (U) botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.

Treatment:

Biological: botulinum toxin Type A (32U)