Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05913102
Status:
UNKNOWN
Last Update Posted:
2023-06-22
First Post:
2023-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
Sponsor:
Jin Cheol Kim
Organization:
Study Overview
Official Title:
A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Juvelook® (VAIM, Korea) is made by dissolving irregular PDLLA particles in a solvent mixture of DMSO (Dimethylsulfoxide) and EC (Ethylene Carbonate) and then injecting them through microneedling to create reticulated foamy microspheres, which are hollow spherical particles. It received CE approval in Europe in 2020 and is widely used domestically as a material for tissue restoration, including skin fillers and collagen stimulators. The spherical shape with internal foam structure of PDLLA exhibits excellent biocompatibility, biodegradability, porosity, and mechanical strength. It allows for the control of particle size and acts as a collagen stimulator while gradually dissolving over time. This stimulates fibroblast cells and promotes skin rejuvenation. In clinical practice, Juvelook® particles are injected to address various concerns such as facial wrinkles, increased elasticity, depressed scars, acne scars, accident scars, under-eye hollows, freckles, whitening effects, and neck wrinkles. Therefore, this study aims to investigate the efficacy of Juvelook® not only in volume augmentation but also in improving photoaged skin.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: