PRIMARY
EFFICACY EVALUATION

ZISHÉL is Non-Inferior

Compared to R-Product

WSRS average difference between R-product applied area and ZISHÉL HA Filler applied area was -0.03 ±0.73. The lowest value of single one-sided 97.5% confidence interval regarding WSRS result was -0.22. As this was bigger value than -0.29 which was the non-inferiority limit in this trial, ZISHÉL HA Filler's non-inferiority was proved.

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SECONDARY
EFFICACY EVALUATION

Patient's Satisfaction

Level

Patient's Satisfaction Level: Among GAI average values evaluated by subject on 8th, 16th, and 24th week, ZISHÉL Filler's satisfaction level was higher than R-product on the 8th and 24th week. However, it is not statistically significant. 

 

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COMPARISON
AMONG
HA FILLERS

 ZISHÉL has similar chemical and physical features with the R-product and J-product, two most well-known brands in the current market.

As shown in the table in the detailed page, ZISHÉL outweighs the both brand' products with respect to the swelling degree and enzyme stability. 

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EFFICACY
TEST

From the internal duration test using mouse, ZISHÉL had longer durability than the J-product and similar durability with the R-product. From the histological test, ZISHÉL  shows the superior result within the material remaining for 4 months and connective tissues. 

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SAFETY
TEST

BDDE Residual Analysis

BDDE which can cause moderate skin irritation, skin sensitization, and allergic reaction is not detected in ZISHÉL. The amount of residual BDDE in ZISHÉL was confirmed through GC analysis. (The detection limit of BDDE: 1 ppm)

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SAFETY
TEST

Animal Studies for

Bio-compatibility

Click to see the bio-compatibility and toxicology tests conducted on ZISHÉL Filler.

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