A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
Overview
- Phase
- Phase 2
- Intervention
- Normal Saline
- Conditions
- Benign Masseteric Hypertrophy
- Sponsor
- Hugel
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Amount of change from baseline in masseter muscle thickness during maximum clenching
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study is A Randomized, Double-blind, Placebo-controlled, Multi-center Phase II Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy
Detailed Description
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase Ⅱ Optimal Dose-finding Study to Evaluate the Safety and Efficacy of Botulax® in Subjects with Benign Masseteric Hypertrophy
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and Female adults aged 19 or older.
- •Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.
- •Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.
- •Subject who voluntarily agree to participate in this clinical trial.
Exclusion Criteria
- •Subject who is clinically significant facial asymmetry in visual measurement by the investigator.
- •Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.
- •Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.
Arms & Interventions
Placebo(Normal Saline)
Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.
Intervention: Normal Saline
Botulinum Toxin Type A(Botulax®) 24Units
Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.
Intervention: Botulinum Toxin Type A Injection (Botulax®) 24Units
Botulinum Toxin Type A(Botulax®) 48Units
Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.
Intervention: Botulinum Toxin Type A Injection (Botulax®) 48Units
Botulinum Toxin Type A(Botulax®) 72Units
Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.
Intervention: Botulinum Toxin Type A Injection (Botulax®) 72Units
Botulinum Toxin Type A(Botulax®) 96Units
Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.
Intervention: Botulinum Toxin Type A Injection (Botulax®) 96Units
Outcomes
Primary Outcomes
Amount of change from baseline in masseter muscle thickness during maximum clenching
Time Frame: Baseline to week 12
Amount of change from baseline in masseter muscle thickness during maximum clenching by Ultrasonography
Secondary Outcomes
- Rate of change from baseline in masseter muscle thickness during maximum clenching(Baseline to week 4, 8, 12, 16)
- Amount of change from baseline in masseter muscle thickness during resting(Baseline to week 4, 8, 12, 16)
- Amount and rate of change from baseline in lower face volume during maximum clenching(Baseline to week 4, 8, 12, 16)
- Amount of change from baseline in masseter muscle thickness during maximum clenching(Baseline to week 4, 8, 16)
- Rate of change from baseline in masseter muscle thickness during resting(Baseline to week 4, 8, 12, 16)
- Overall satisfaction of subject(Baseline to week 4, 8, 12, 16)
- Overall improvement of Investigator(Baseline to week 4, 8, 12, 16)