Overview

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

Status:
Completed
Trial end date:
2017-11-29
Target enrollment:
0
Participant gender:
All
Summary
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
incobotulinumtoxinA
onabotulinumtoxinA
Criteria
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)