Clinical trial NCT05913102: A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
Official title: A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pigmentation
Pigmentation Disorder
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel assignment split lesion study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: change of lightness value
timeFrame: Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.
Secondary outcomes:
measure: patinent global assessment for skin condition
timeFrame: Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.
measure: investigator global assessment score for pigmentation
timeFrame: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.
measure: Fitzpatrick wrinkle and elastosis scale
timeFrame: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
References: