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

Hugel

Status and phase: Completed; Phase 2

Conditions: Benign Masseteric Hypertrophy

Treatments: Other: Normal Saline; Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units; Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units; Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units; Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units

Study type: Interventional

Funder types: Industry

Identifiers

NCT04443244

HG-BOTBMH-PII-01

Details and patient eligibility

About

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

Full 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

Enrollment: 80 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 5 patient groups, including a placebo group

Botulinum Toxin Type A(Botulax®) 24Units

Experimental group

Description:

Botulinum Toxin Type A (Botulax®) 24Units total dose administered intramuscularly to the bilateral masseter muscles.

Treatment:

Drug: Botulinum Toxin Type A Injection (Botulax®) 24Units

Botulinum Toxin Type A(Botulax®) 48Units

Experimental group

Description:

Botulinum Toxin Type A (Botulax®) 48Units total dose administered intramuscularly to the bilateral masseter muscles.

Treatment:

Drug: Botulinum Toxin Type A Injection (Botulax®) 48Units

Botulinum Toxin Type A(Botulax®) 72Units

Experimental group

Description:

Botulinum Toxin Type A (Botulax®) 72Units total dose administered intramuscularly to the bilateral masseter muscles.

Treatment:

Drug: Botulinum Toxin Type A Injection (Botulax®) 72Units

Botulinum Toxin Type A(Botulax®) 96Units

Experimental group

Description:

Botulinum Toxin Type A (Botulax®) 96Units total dose administered intramuscularly to the bilateral masseter muscles.

Treatment:

Drug: Botulinum Toxin Type A Injection (Botulax®) 96Units

Placebo(Normal Saline)

Placebo Comparator group

Description:

Placebo(Normal saline) administered intramuscularly to the bilateral masseter muscles.

Treatment:

Other: Normal Saline