A Safety and Efficacy Study of OnabotulinumtoxinA in Forehead and Glabellar Facial Rhytides

Allergan

Status and phase: Completed; Phase 3

Conditions: Glabellar Rhytides; Forehead Rhytides

Treatments: Drug: Normal Saline; Biological: OnabotulinumtoxinA

Study type: Interventional

Funder types: Industry

Identifiers

NCT02261467

191622-142

2014-001860-36 (EudraCT Number)

Details and patient eligibility

About

This is a safety and efficacy study of onabotulinumtoxinA in subjects with forehead and glabellar facial rhytides (frown lines).

Enrollment: 421 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe forehead and glabellar lines
• Willing to have facial photos taken

Exclusion criteria

• Prior exposure to botulinum toxin of any serotype for any indication
• Anticipated need for treatment with botulinum toxin of any serotype for any indication during the study, other than study treatment
• Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
• Any facial resurfacing laser or light treatment, microdermabrasion, or superficial peels in the past 3 months
• Any medium depth or deep depth facial chemical peels; facial skin resurfacing; or permanent facial make-up in the past 6 months
• Any nonpermanent soft tissue fillers, or treatment with oral retinoids in the past year
• Prior face lift, thread lift, eyebrow lift, or related procedures (eg, eyelid and/or eyebrow surgery)
• Prior facial treatment with permanent soft tissue fillers, synthetic implants (eg, Gore-Tex®), and/or fat transplantation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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421 participants in 2 patient groups, including a placebo group

OnabotulinumtoxinA

Experimental group

Description:

OnabotulinumtoxinA injected into the protocol-specified areas on Day 1. Subjects will receive at least 1 and up to 3 treatments.

Treatment:

Biological: OnabotulinumtoxinA

Placebo followed by OnabotulinumtoxinA in Period 2

Placebo Comparator group

Description:

Placebo (normal saline) injected into the protocol-specified areas on Day 1. If the subject meets the re-treatment criteria in Period 2, the subject will receive up to 2 open-label treatments with onabotulinumtoxinA into the protocol-specified areas.

Treatment:

Drug: Normal Saline