Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Forehead and Frown Lines

A Multi-Centre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Single Treatment Cycle Study of BOTOX® Cosmetic (Botulinum Toxin Type A) Purified Neurotoxin Complex in Subjects With Forehead and Glabellar Rhytides

This study evaluated the safety and efficacy of botulinum toxin Type A compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).

Inclusion Criteria:

• Moderate to severe forehead lines

Exclusion Criteria:

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