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A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin

J

Jin Cheol Kim

Status

Active, not recruiting

Conditions

Pigmentation Disorder
Pigmentation

Treatments

Drug: PDLLA

Study type

Interventional

Funder types

Other

Identifiers

NCT05913102
AJOUIRB-INT-2021-630

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

Female

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Healthy adult women over 30 years old with photoaged skin.
  2. Individuals who have a clear understanding of the purpose and content of the study, as well as the potential risks and side effects, and voluntarily sign the informed consent form to participate in the clinical trial.
  3. Individuals who are physically healthy and can be tracked and observed throughout the entire study period.

Exclusion criteria

  1. Individuals who have received anti-aging/whitening treatments (such as laser or chemical peels) on their face within 3 months prior to the start of the study.
  2. Individuals who have applied anti-aging/whitening agents to their face within 3 months prior to the start of the study.
  3. Pregnant or breastfeeding women.
  4. Individuals who are participating in other clinical trials.
  5. Individuals who, in the judgment of the researchers, are deemed ineligible to participate in the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

experimental
Experimental group
Description:
administer PDLLA
Treatment:
Drug: PDLLA
active comparator
Active Comparator group
Description:
administer saline
Treatment:
Drug: PDLLA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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