R&D Center
Developing Next-Generation DermalFillers and Skin Care Cosmetics Based on
Hyaluronic Acid Cross-Linking Technology and Safe Crosslinker Removal Techniques
01
Biostandard manufactures products with uniform cross-linking rate and separation and purification technology through the 3S.S Process.
02
- Very low level of BDDE detection (Biostandard's quality standard for BDDE detection is 2ppm or less, but in reality, it is undetectable)
- Endotoxin and protein load are managed at lower levels compared to other companies
| Item | Impact | Biostandard | Company A | Company B |
|---|---|---|---|---|
| Endotoxin (EU/mL) |
Inflammation | < 0.03 | 0.5 | 0.5 |
| BDDE (ppm) |
Allergic Reaction | < 2 (Non-detection level) |
< 2 | < 2 |
| Protein Load (ppm) |
Allergic Reaction | < 0.03 | < 0.06 | < 0.05 |
03
A clinical trial was conducted in comparison with Company G (BHA), which is widely used for deep wrinkles, and the efficacy, safety,
and sustainability of wrinkle improvement were proven through visual evaluation (WSRS) 6 months after injection.
MELINE No.3 (MHA) showed superior effectiveness with WSRS scores approximately 0.10points higher than Company G’s (BHA) product.
Table 1. Comparison of the efficacy of BHA and MHA fillers for wrinkle improvement
* Number of Test Subjects: 91, 90
| Variable | Evaluator | Time | Mean ± SD | Range | P-value | ||
|---|---|---|---|---|---|---|---|
| BHA | MHA | BHA | MHA | ||||
| Average WSRS score [n=91] |
Independent evaluators |
8wk | 2.11±0.72 | 2.01±0.71 | 1.0~4.0 | 0.055 | |
| 24wk | 2.17±0.72 | 2.07±0.71 | 1.0~4.0 | 0.034 | |||
※ WSRS : Wrinkle Severity Rating Scale
Ref. Comparison of the efficacy and safety between a new monophasic hyaluronic acid filler and
a biphasic hyaluronic acid filler in correcting facial wrinkles. Arch Aesthetic Plast Surg 2023;29(3):141-146
04
Right after injection, MELINE No.3 (MHA) showed a slightly higher VAS value than Company G (BHA)'s.
However, 15 minutes after the procedure, the VAS value of MELINE No. 3 (MHA) decreased from 2.20 points to 0 points, and the VAS value of Company G (BHA) decreased from 1.67 points to 0.79 points and has been maintained.
※ VAS : Visual Analogue Scale(Pain Sclale 0~10 points)
The subject's level of pain during the procedure is evaluated on a scale of 0 to 10.
| VAS(n=91) | BHA (LYFT) | MHA (No.3) | ||||
|---|---|---|---|---|---|---|
| Mean | SD | Min, Max | Mean | SD | Min, Max | |
| After 0 min | 1.37 | 1.19 | 0.0, 6.0 | 2.20 | 1.44 | 0.0, 8.0 |
| After 15 min | 0.79 | 1.22 | 0.0, 0.0 | 0.0 | 0.0 | 0.0, 0.0 |
| After 30 min | 0.0 | 0.0 | 0.0, 0.0 | 0.0 | 0.0 | 0.0, 0.0 |
| VAS (n=91) |
BHA (LYFT) | ||
|---|---|---|---|
| Mean | SD | Min, Max |
|
| After 0 min |
1.37 | 1.19 | 0.0, 6.0 |
| After 15 min |
0.79 | 1.22 | 0.0, 0.0 |
| After 30 min |
0.0 | 0.0 | 0.0, 0.0 |
| VAS (n=91) |
MHA (No.3) | ||
|---|---|---|---|
| Mean | SD | Min, Max |
|
| After 0 min |
2.20 | 1.44 | 0.0, 8.0 |
| After 15 min |
0.0 | 0.0 | 0.0, 0.0 |
| After 30 min |
0.0 | 0.0 | 0.0, 0.0 |
Ref. Comparison of the efficacy and safety between a new monophasic hyaluronic acid filler and
a biphasic hyaluronic acid filler in correcting facial wrinkles. Arch Aesthetic Plast Surg 2023;29(3):141-146
