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

NCT ID: NCT04443244

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-27

Study Completion Date

2021-07-16

Brief Summary

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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

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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

Conditions

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Benign Masseteric Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Botulinum Toxin Type A(Botulax®) 24Units

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

Group Type EXPERIMENTAL

Botulinum Toxin Type A Injection (Botulax®) 24Units

Intervention Type DRUG

Experimental: Botulax® 24Units

Botulinum Toxin Type A(Botulax®) 48Units

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

Group Type EXPERIMENTAL

Botulinum Toxin Type A Injection (Botulax®) 48Units

Intervention Type DRUG

Experimental: Botulax® 48Units

Botulinum Toxin Type A(Botulax®) 72Units

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

Group Type EXPERIMENTAL

Botulinum Toxin Type A Injection (Botulax®) 72Units

Intervention Type DRUG

Experimental: Botulax® 72Units

Botulinum Toxin Type A(Botulax®) 96Units

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

Group Type EXPERIMENTAL

Botulinum Toxin Type A Injection (Botulax®) 96Units

Intervention Type DRUG

Experimental: Botulax® 96Units

Placebo(Normal Saline)

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

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

Placebo Comparator: Normal Saline

Interventions

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Botulinum Toxin Type A Injection (Botulax®) 24Units

Experimental: Botulax® 24Units

Intervention Type DRUG

Botulinum Toxin Type A Injection (Botulax®) 48Units

Experimental: Botulax® 48Units

Intervention Type DRUG

Botulinum Toxin Type A Injection (Botulax®) 72Units

Experimental: Botulax® 72Units

Intervention Type DRUG

Botulinum Toxin Type A Injection (Botulax®) 96Units

Experimental: Botulax® 96Units

Intervention Type DRUG

Normal Saline

Placebo Comparator: Normal Saline

Intervention Type OTHER

Other Intervention Names

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Botulax® Botulax® Botulax® Botulax®

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hugel

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hugel

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HG-BOTBMH-PII-01

Identifier Type: -

Identifier Source: org_study_id