Clinical Trial: Medytoxin® Treatment in Patients With Benign Masseteric Hypertrophy
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine Safety and Efficacy of Medytoxin® in Subjects in Benign Masseteric Hypertrophy
Brief Summary: This study design is A Randomized, Double-blind, Multi-center, Phase II Optimal Dose-finding Study to Determine the Safety and Efficacy of Meditoxin® in Subjects in Benign Masseteric Hypertrophy.
Detailed Summary: Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the placebo to find appropreate dose for the treatment of Benign Masseteric Hypertrophy. Thereafter, follow-up visits will be made and efficacy and safety assessment will be conducted.
Sponsor: Medy-Tox
Current Primary Outcome: Reduction amount of masseter muscle thickness [ Time Frame: after the injection ]
Original Primary Outcome: Reduction amount of masseter muscle thickness with maximun clenching [ Time Frame: 12 weeks after the injection ]
Current Secondary Outcome:
- Reduction amount of masseter muscle thickness and lower face volume [ Time Frame: after the injection ]
- Overall satisfaction of subject [ Time Frame: after the injection ]
Original Secondary Outcome:
- Reduction amount of masseter muscle thickness with maximun clenching [ Time Frame: 4 weeks and 8 weeks after the injection ]
- Reduction amount of masseter muscle thickness with resting [ Time Frame: 4 weeks, 8 weeks and 12 weeks after the injection ]
- Reduction amount of lower face volumn [ Time Frame: 4 weeks, 8 weeks and 12 weeks after the injection ]
- Overall satisfaction of subject [ Time Frame: 4 weeks, 8 weeks and 12 weeks after the injection ]
Information By: Medy-Tox
Dates:
Date Received: November 12, 2014
Date Started: August 2014
Date Completion: August 2015
Last Updated: May 26, 2015
Last Verified: May 2015