Phase
Condition
N/ATreatment
Placebo
BOTOX
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Body mass index < 30 kg/m^2 using the calculation: BMI = weight (kg)/height (m)^2,rounded to the nearest whole number.
Participants meets the following criteria:
Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right side ofthe face), as determined at screening and at the Day 1 visit by theinvestigator using the MMPS.
Bilateral Grade 4 or Grade 5 MMP (identical grades for left and right sides ofthe face), as determined at the Day 1 visit by the participant using theMMPS-P.
MMP grades, as assessed by investigator and participant, do not need to beidentical but have to be a minimum of Grade 4 with bilateral symmetry at Day 1.
Participants who responded "A lot" or "Extremely" bothered by the appearance oftheir MMP as measured by the Bother Impact Assessment for Masseter Muscle Prominence (BIA-MMP) and attain a total score of ≥ 15 on the Lower Facial Shape Questionnaire -Impact Assessment (LFSQ-IA), determined at the Day 1 visit.
Exclusion
Exclusion Criteria:
Has current intraoral infection, including infection of the mouth or gums, or facialskin infection requiring medical treatment in the opinion of the investigator.
Has weakness of the masseter, pterygoid, or temporalis muscles due to trauma, facialnerve injury, or other condition that could interfere with normal chewing and jawclenching, as determined by the investigator.
Excess lower facial fat, jowling, loose or lax skin in lower face, or parotid glandprominence that could interfere with MMPS or MMPS-P grading, as determined by theinvestigator.
Has medical condition that may put the participant at increased medical risk withexposure to BOTOX, including diagnosed myasthenia gravis, Eaton-Lambert syndrome,amyotrophic lateral sclerosis, or any other condition that might interfere withneuromuscular function.
History of dental or surgical procedure for lower facial shaping or masseter musclereduction.
History of any soft tissue fillers in the jawline.
Has prior exposure to botulinum toxin of any serotype to any part of the body (notincluding masseter muscle) within the 3 months prior to Day 1.
History of or current TMJD, or presence of signs/symptoms of possible TMJD in theopinion of the investigator.
Study Design
Connect with a study center
Da Vinci Clinic /ID# 246731
Beerse, Antwerpen 2340
BelgiumSite Not Available
Evolve Clinic /ID# 246729
Schilde, Antwerpen 2970
BelgiumSite Not Available
Universitair Ziekenhuis Brussel /ID# 246311
Jette, Bruxelles-Capitale 1090
BelgiumSite Not Available
Lightfalls Clinic /ID# 247335
Melle, Oost-Vlaanderen 9090
BelgiumSite Not Available
Dermavist - Group Practice for Specialized Medical Care for Skin Disease /ID# 247630
Plovdiv, 4000
BulgariaSite Not Available
Medical Centre Dermatology Dr. Denkova EOOD /ID# 246591
Sofia, 1700
BulgariaSite Not Available
Medical Center Derma Vita EOOD /ID# 247327
Sofiya, 1407
BulgariaSite Not Available
Mediti /Id# 246875
Antibes, 06160
FranceSite Not Available
Cabinet Dermatologie et Esthetique /ID# 246871
Cannes, 06400
FranceSite Not Available
Cabinet médical /ID# 246873
Paris, 75007
FranceSite Not Available
Cabinet de Chirurgie Plastique et Esthétique /ID# 246872
Toulouse, 31000
FranceSite Not Available
Hautok and Hautok-cosmetics /ID# 246600
Muenchen, Bayern 80333
GermanySite Not Available
Studienzentrum Theatiner46 /ID# 246601
Muenchen, Bayern 80333
GermanySite Not Available
Privatpraxis Dr. Hilton & Partner /ID# 246602
Duesseldorf, Nordrhein-Westfalen 40212
GermanySite Not Available
Hautzentrum Koeln /ID# 247502
Koeln, Nordrhein-Westfalen 50996
GermanySite Not Available
Universitaet Hamburg /ID# 247503
Hamburg, 20146
GermanySite Not Available
Fondazione Policlinico Universitario Campus Bio-Medico di Roma /ID# 246836
Rome, Roma 00128
ItalySite Not Available
Azienda Unita Sanitaria Locale Latina /ID# 246835
Latina, 04100
ItalySite Not Available
Fondazione Policlinico Universitario Campus Bio-Medico /ID# 246836
Roma, 00128
ItalySite Not Available
CRC - Centro Ricerche Cliniche di Verona S.r.l. /ID# 246834
Verona, 37134
ItalySite Not Available
Gavín Dermatólogos /ID# 252120
Vigo, Pontevedra 36201
SpainSite Not Available
Clinica Alejandria /ID# 247380
València, Valencia 46004
SpainSite Not Available
Clinica Robega /ID# 252239
Madrid, 28008
SpainSite Not Available
Grupo Pedro Jaen /ID# 246485
Madrid, 28006
SpainSite Not Available
Waverley Medical Practice /ID# 246432
Coatbridge, Lanarkshire ML5 3AP
United KingdomSite Not Available
Dr Nestor's Medical Cosmetic Centre /ID# 246437
Edinburgh, EH3 6RS
United KingdomSite Not Available
Interface Aesthetics Training Limited /ID# 248115
London, W1H 6AZ
United KingdomSite Not Available
MediZen /ID# 246431
Sutton Coldfield, B74 2UG
United KingdomSite Not Available
MediZen Premier Aesthetic Clinic /ID# 246431
Sutton Coldfield, B74 2UG
United KingdomActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.