Evaluate the Safety and Efficacy of Botulax® in Subjects With Benign Masseteric Hypertrophy

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hugel
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

1. Male and Female adults aged 19 or older.

2. Sighting, facilitation measurement are judged by the investigator to be the ratio of Benign Masseteric Hypertrophy.

3. Subject who understand and willing to perform with the procedures and visiting schedules of clinical trial.

4. Subject who voluntarily agree to participate in this clinical trial.

Exclusion Criteria:

1. Subject who is clinically significant facial asymmetry in visual measurement by the investigator.

2. Fertile women and men who have plans to conceive during pregnancy, breastfeeding and clinical trials or who do not agree to appropriate contraception.

3. Subject who is deemed unable to participate in a clinical trial under the judgement of a Investigator.