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

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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

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

Trial documents
2

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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