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What is Regenox?
Regenox is Purified Botulium Toxin type A Complex developed by medical doctors and researchers in Korea. Botulium Toxin is a material comes from bacteria gClostridium botulinumh. Regenox is used for a beauty such as removing wrinkles, quadrangular chin correction and treatment all kinds of neuromuscular disease.

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Ingredients of Regenox

- Botulinum toxin type A neurotoxin : purified from Clostridium

  botulinum type A (genetically identical to ATCC 3502)

- Albumin : Human serum albumin, bulking and stabilizing agent

  and adhesion reducer, KP grade

- NaCI : bulking agent and keeping isotonicity during formulation,

  KP grade

 

Advantages of Regenox

- Regenox is convenience to inject topically because it has higher

  titer than other Botulinum toxin.

- Repeatable injection can be possible.

- Preclinical study has been performed for 5 years.

 

Clinical Indications

- Mouth Feet, Forhead Lines, Crowfs Feet

- The ridge of the nose, Glabellar Lines

- Blepharospasm, Hemifacial Spasm

- Vocal Chords Hypertropy

- Masseteric/Calf Muscle Hypertropy

- Migraine

- Back Pain

- Anal Fissure, Pile

- Forhead Lines, Nose Axilla(Armpit) Palm, Sole

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- Mechanism of action 

Blocking up the secretion of Acetylcholine which sends signal from the edge of nerve to the tissue Blocking up the nerve conduction

Causing temporary paralysis of muscle and inhibits muscle contractions Improving the symptoms of massive muscle contractions or muscle convulsions

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- Advantages and disadvantages

Botulinum Toxin is the safest and most effective treatment. It does not have any bad effects on the whole body and convulsions are marvelously diminished over 90% of patients. Effects of medicine are not permanent. Repeatable injection is required.

  

   Product of Quality Regenox

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Clinical Study of Regenox

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Title of Clinical Study: Phase I Clinical Trial to Confirm the Safety of gRegenoxh in Essential Blepharospasm

Procedures: single group, uncontrolled, multicenter study

Indications: Essential blepharospasm

Patient Criteria:

Adults of above age 18 and below age 75

Patients with essential blepharospasm of which degree of spasm is Grade 2~4(Scott method)

 

Results of Clinical Study

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1. Efficacy

Table 1 Degree of Spasm, 4 Weeks After Administration, ITT Group

 

Test Group

 

n

mean+std

min~max

Before administration

21

3.38+0.59

2.00~4.00

At 4th Week

21

2.05+1.12

0.00~3.00

Improvement

21

-2.33+0.97

-4.00~1.00

 

Table 2 Degree of Spasm, 4 Weeks After Administration, PP Group

 

Test Group

 

n

mean+std

min~max

Before administration

21

3.40+0.60

2.00~4.00

At 4th Week

21

1.05+1.12

0.00~3.00

Improvement

21

-2.40+0.94

-4.00~1.00

 

2. Safety

1. Test product was administred into total 21 subjects(ITT analysis group). One subject violated the protocol(raking a drug prohibited during the study period). As a result, the subject was excluded from the group for PP analysis. Accordiingly, the number of subjects who completed the study in compliance with the protocol was 20 and dropout rate was 4.76%.

2. Eight adverse events were observed in 7 subjects out of 21 subjected the test product. Therefore, the frequency was 38.10%. Adverse events were mild swollen lids, edema, tears, dry eye, muscae volitantes, and allergic conjunctivitis. In the check of vital signs and laboratory tests, any abnormal values were not found.

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