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

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 Overview

• Status: Active, not recruiting
• Conditions: Pigmentation Disorder; Pigmentation
• Intervention / Treatment: Drug: PDLLA

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of
    • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental; administer PDLLA	Drug: PDLLA; Administer PDLLA/saline every 2 weeks for 2.5 months
Active Comparator: active comparator; administer saline	Drug: PDLLA; Administer PDLLA/saline every 2 weeks for 2.5 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jin Cheol Kim

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: June 10, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 10, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Pigmentation Disorders
• Other Study ID Numbers: AJOUIRB-INT-2021-630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No