Status:
COMPLETED
Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy
Lead Sponsor:
Hugel
Conditions:
Benign Masseteric Hypertrophy
Eligibility:
All Genders
19+ years
Phase:
PHASE2
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 Hypert...
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04443244
Start Date
May 27 2020
End Date
July 16 2021
Last Update
November 16 2021
Active Locations (1)
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1
Hugel
Seoul, South Korea