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

Jin Cheol Kim40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pigmentation Pigmentation Disorder

Eligibility

Sex: FEMALEMin age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

change of lightness value

change of lightness value by a chromometer

Time frame: Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.

Secondary Outcomes

patinent global assessment for skin condition

patinent global assessment for skin condition by a self-questionnaire

Time frame: Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.

investigator global assessment score for pigmentation

investigator global assessment score for pigmentation by clinical photos

Time frame: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.

Fitzpatrick wrinkle and elastosis scale

Fitzpatrick wrinkle and elastosis scale by clinical photos

Time frame: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment