NCT04073303

BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence

Brief summary

This study is designed to evaluate the safety and effectiveness of administering BOTOX for the treatment of Masseter Muscle Prominence (MMP) in adults.

Interventional study

Status:
Completed
Conditions:
Masseter Muscle Prominence
Enrollment:
377 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
1789-301-008
Allocation:
Randomized
Intervention model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

18 Years and older.

Inclusion Criteria:

Inclusion Criteria:

- Masseter prominence at the Day 1 visit

- BMI ≤ 30 kg/m2 using the calculation: BMI = weight (kg)/[height (m)]2

- A female participant must be willing to minimize the risk of inducing pregnancy for
the duration of the clinical study and follow-up periods

Exclusion Criteria:

- Any medical condition that may put the participant at increased medical risk with
exposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome,
amyotrophic lateral sclerosis, or any other condition that might interfere with
neuromuscular function

- An anticipated need for surgery or overnight hospitalization during the study

- An anticipated need for treatment with botulinum toxin of any serotype for any
indication during the study (other than study intervention)

- History of dental or surgical procedure for lower facial shaping or masseter muscle
reduction

- Prior mid-facial and/or lower facial treatment with nonpermanent soft tissue
fillers, synthetic implantations, autologous fat transplantation, fat-reducing
injectables, and/or skin-tightening laser treatments within 6 months prior to Day 1

- Prior exposure to botulinum toxin of any serotype to the masseter muscle or lower
face at any time, or to any other part of the body within the 6 months prior to Day
1

- History of temporomandibular joint disorder (TMJD)

- Masseter prominence due to other etiologies (eg, parotid gland infection,
parotiditis, malignancy)

- Known allergy or sensitivity to any of the components of the study treatments or any
materials used in the study procedures

- History of alcohol or drug abuse within 12 months of Day 1

All the cities where the clinical studies are located

Calgary - T3E 0B2
Vancouver - V5Z 4E1
Vancouver - V6H 1K9
Vancouver - V6H 4E1
Richmond Hill - L4B 1A5

Alberta

British Columbia

More information about this study

clinicaltrials.gov