BOTOX® Treatment for Adults With a Wide Lower Face Due to Masseter Muscle Prominence
NCT ID: NCT04073303
Last Updated: 2025-05-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
377 participants
INTERVENTIONAL
2019-08-29
2022-11-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum Toxin Type A (BOTOX®)
Botulinum Toxin Type A (BOTOX ®) will be administered on Day 1 as bilateral intramuscular injections into the masseter with the possibility of 2 additional treatments
Botulinum Toxin Type A
Day 1 Administration of bilateral intramuscular injections into the masseter
Placebo
Placebo (normal saline) will be administered on Day 1 as bilateral intramuscular injections into the masseter
Placebo
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter
Interventions
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Botulinum Toxin Type A
Day 1 Administration of bilateral intramuscular injections into the masseter
Placebo
Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Duplicate_Beacon Dermatology Inc /ID# 233018
Calgary, Alberta, Canada
Duplicate_Humphrey Cosmetic Dermatology /ID# 232764
Vancouver, British Columbia, Canada
Project Skin MD LTD /ID# 232763
Vancouver, British Columbia, Canada
Pacific Derm /ID# 233156
Vancouver, British Columbia, Canada
The Center For Dermatology /ID# 233001
Richmond Hill, Ontario, Canada
Peking University Third Hospital /ID# 233148
Beijing, Beijing Municipality, China
Duplicate_Peking Union Medical College Hospital /ID# 233072
Beijing, Beijing Municipality, China
Chinese PLA General Hospital /ID# 233158
Beijing, Beijing Municipality, China
Peking University First Hospital /ID# 232973
Xicheng District, Beijing Municipality, China
Tianjin Medical University General Hospital /ID# 232961
Tianjin, Guizhou, China
Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 233008
Wuhan, Hubei, China
Xiangya Hospital Central South University /ID# 233027
Changsha, Hunan, China
Nanjing Drum Tower Hospital /ID# 233016
Nanjing, Jiangsu, China
Zhongda Hospital Southeast University /ID# 232836
Nanjing, Jiangsu, China
Shanghai Ninth People's Hospital,Shanghai Jiaotong University School of Medicine /ID# 232656
Shanghai, Shanghai Municipality, China
Tangdu Hospital of The Fourth Military Medical University, PLA /ID# 233087
Xi’an, Shanxi, China
West China Hospital, Sichuan University /ID# 233107
Chengdu, Sichuan, China
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 233033
Kaohsiung City, Keelung, Taiwan
National Taiwan University Hospital /ID# 233133
Taipei City, Taipei, Taiwan
Taipei Medical University Hospital /ID# 233009
Taipei, , Taiwan
Tri-Service General Hospital /ID# 233080
Taipei, , Taiwan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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1789-301-008
Identifier Type: -
Identifier Source: org_study_id
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