Botulinum Toxin Type A (BOTOX®) Treatment of Masseter Muscle Hypertrophy

Allergan

Status and phase: Completed; Phase 2

Conditions: Masseter Muscle Hypertrophy

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02010775

191622-130

Details and patient eligibility

About

This study will evaluate the safety and efficacy of a range of doses of botulinum toxin Type A (BOTOX®) for the treatment of patients with bilateral Masseter Muscle Hypertrophy (MMH).

Enrollment: 187 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

-Participants with Masseter Muscle Hypertrophy

Exclusion criteria

• Diagnosis of Myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
• Prior botulinum toxin treatment of any serotype to the masseter muscle or lower face
• History of dental or surgical procedure for lower facial shaping or masseter muscle reduction
• History of or current temporomandibular joint disorder (TMJD)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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187 participants in 5 patient groups, including a placebo group

BOTOX® 24U

Active Comparator group

Description:

Botulinum Toxin Type A (BOTOX®) 24U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Treatment:

Biological: botulinum toxin Type A

BOTOX® 48U

Active Comparator group

Description:

Botulinum Toxin Type A (BOTOX®) 48U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Treatment:

Biological: botulinum toxin Type A

BOTOX® 72U

Active Comparator group

Description:

Botulinum Toxin Type A (BOTOX®) 72U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Treatment:

Biological: botulinum toxin Type A

BOTOX® 96U

Active Comparator group

Description:

Botulinum Toxin Type A (BOTOX®) 96U total dose administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Treatment:

Biological: botulinum toxin Type A

Placebo

Placebo Comparator group

Description:

Placebo (Normal saline) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.

Treatment:

Drug: Normal saline