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

Allergan

Status: Completed

Conditions: Facial Rhytides; Glabellar Frown Lines

Treatments: Drug: Normal Saline; Biological: botulinum toxin Type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01391299

GMA-BTXC-10-002

Details and patient eligibility

About

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).

Enrollment: 175 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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175 participants in 3 patient groups, including a placebo group

botulinum toxin Type A (40 Units)

Active Comparator group

Description:

Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.

Treatment:

Biological: botulinum toxin Type A

botulinum toxin Type A (30 Units)

Active Comparator group

Description:

Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.

Treatment:

Biological: botulinum toxin Type A

placebo (Normal saline)

Placebo Comparator group

Description:

Placebo (Normal saline) injected into bilateral forehead and frown line areas on Day 1.

Treatment:

Drug: Normal Saline