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

NCT05913102 | Unknown

• 1 other identifier: AJOUIRB-INT-2021-630
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pigmentation; Pigmentation Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• patinent global assessment for skin condition

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

• investigator global assessment score for pigmentation

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

• Fitzpatrick wrinkle and elastosis scale

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

Study Arms (2)

experimental

EXPERIMENTAL

administer PDLLA

Drug: PDLLA

active comparator

ACTIVE COMPARATOR

administer saline

Drug: PDLLA

Interventions

PDLLA DRUG

Administer PDLLA/saline every 2 weeks for 2.5 months

active comparator; experimental

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jin Cheol Kim: lead

Study Sites (1)

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, research assistant professor

Model Details: parallel assignment split lesion study

Study Record Dates

• First Submitted: June 10, 2023
• First Posted: June 22, 2023
• Study Start: September 28, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)