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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01224015

2010-021271-83 (EudraCT Number)

191622-104

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) for patients who successfully completed Study 191622-099.

Enrollment: 684 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successfully completed Study 191622-099

Exclusion criteria

• Known immunization or hypersensitivity to botulinum toxin of any serotype
• Anticipated need for treatment with botulinum toxin of any serotype during the study (except for study treatment)
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Anticipated need for surgery or hospitalization during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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684 participants in 3 patient groups, including a placebo group

onabotulinumtoxinA 24U

Other group

Description:

24 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Treatment:

Drug: normal saline

Biological: onabotulinumtoxinA 24 U

placebo (normal saline)

Placebo Comparator group

Description:

Normal Saline (placebo) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Treatment:

Drug: normal saline

onabotulinumtoxinA 44U

Experimental group

Description:

44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.

Treatment:

Biological: onabotulinumtoxinA 44 U