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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pigmentation, Pigmentation Disorder

Intervention / Treatment
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* Drug: PDLLA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult women over 30 years old with photoaged skin. 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. Individuals who are physically healthy and can be tracked and observed throughout the entire study period. Exclusion Criteria: 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. Individuals who have applied anti-aging/whitening agents to their face within 3 months prior to the start of the study. Pregnant or breastfeeding women. Individuals who are participating in other clinical trials. Individuals who, in the judgment of the researchers, are deemed ineligible to participate in the study.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: parallel assignment split lesion study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental<br>administer PDLLA | Drug: PDLLA<br>* Administer PDLLA/saline every 2 weeks for 2.5 months<br>|
| Active Comparator: active comparator<br>administer saline | Drug: PDLLA<br>* Administer PDLLA/saline every 2 weeks for 2.5 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of lightness value | change of lightness value by a chromometer | Chromometer will be taken before treatment and 4,8,12 weeks after last treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patinent global assessment for skin condition | patinent global assessment for skin condition by a self-questionnaire | 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 | 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 | Photos will be taken before each treatment and 4,8,12 weeks after the final treatment |