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

Not Applicable

Active, not recruiting

• Conditions: Pigmentation Disorder; Pigmentation
• Interventions: Drug: PDLLA

• Registration Number: NCT05913102
• Lead Sponsor: Jin Cheol Kim

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

Not available

Study Timeline

• Study Start: 2022-09-28
• Status Verified: 2023-06
• Study First Submitted: 2023-06-10
• Study First Submitted QC: 2023-06-10
• Last Update Submitted: 2023-06-10
• Study First Posted: 2023-06-22
• Last Update Posted: 2023-06-22
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	PDLLA	administer PDLLA
active comparator	PDLLA	administer saline

Primary Outcome Measures

Name	Time	Method
change of lightness value	Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.	change of lightness value by a chromometer

Secondary Outcome Measures

Name	Time	Method
investigator global assessment score for pigmentation	Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.	investigator global assessment score for pigmentation by clinical photos
Fitzpatrick wrinkle and elastosis scale	Photos will be taken before each treatment and 4,8,12 weeks after the final treatment	Fitzpatrick wrinkle and elastosis scale by clinical photos
patinent global assessment for skin condition	Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.	patinent global assessment for skin condition by a self-questionnaire

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of