Evaluation the safety and efficacy for gastrocnemius hypertrophy of Botox injectio

Not Applicable

Active, not recruiting

• Conditions: Factors influencing health status and contact with health services

• Registration Number: KCT0008039
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1) A person between the ages of 20 and 60 who want contour correction of the gastrocnemius muscle
2) A person who can follow the clinical trial procedure well and abide by the visit schedule
3) Those who voluntarily signed the consent form

Exclusion Criteria

1) Patients with diseases that can affect neuromuscular function, such as myasthenia gravis, Eaton-Lamberton syndrome, amyotrophic lateral sclerosis, and motor neuropathy
2) Aminoglycoside antibiotics, curare-like agents, or drugs that inhibit neuromuscular function (muscle relaxants such as tubocurarine, dancrolen sodium, and baclofen, anticholinergics, and benzodiazepines) antibiotics, benzamide, tetracycline, lincomycin antibiotics, etc.)
3) Patients with a history of recent alcoholism or drug misuse
4) Patients with skin abnormalities such as infections, skin diseases, or scars at the injection site
5) If you have had other procedures that may affect gastrocnemius treatment within 6 months prior to baseline
6) Those who have received botulinum toxin preparations within 6 months before baseline
7) Patients with a history of facial nerve palsy or ptosis
8) Those taking aspirin, NSAIDs or anticoagulants
9) A woman who is pregnant, lactating, or of childbearing potential who does not agree to contraception by a medically accepted method for up to 8 weeks after drug administration
10) A person who has rapidly lost weight
11) Patients who are allergic or sensitive to investigational drugs or their ingredients
12) Those who are currently suffering from an acute disease
13) Those suffering from severe heart disease or respiratory disease
14) Patients who have participated in another clinical trial within 30 days before baseline or who have not passed the longer period of 5 times the half-life of the investigational drug of the clinical trial they participated in
15) Other patients who are not suitable for this test under the judgment of the investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluated by measuring the circumference of the calf at the thickest part while raising the heel after 8 weeks of administration compared to before administration = Calf circumference after 8 weeks - Calf circumference before injection;Adverse effect

Secondary Outcome Measures

Name	Time	Method
Evaluation of subject satisfaction after 8 weeks of injection compared to before injection;Vital sign (Blood pressure, pulse, body temperature);Laboratory findings (CBC, BUN, Cr, Protein, Albumin, AST, ALT, Alkaline phosphatase, Sodium, Potassium, Chloride, Calcium)