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

Primary Purpose

Pigmentation, Pigmentation Disorder

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PDLLA
Sponsored by
Jin Cheol Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pigmentation

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental

active comparator

Arm Description

administer PDLLA

administer saline

Outcomes

Primary Outcome Measures

change of lightness value
change of lightness value by a chromometer

Secondary Outcome Measures

patinent global assessment for skin condition
patinent global assessment for skin condition by a self-questionnaire
investigator global assessment score for pigmentation
investigator global assessment score for pigmentation by clinical photos
Fitzpatrick wrinkle and elastosis scale
Fitzpatrick wrinkle and elastosis scale by clinical photos

Full Information

First Posted
June 10, 2023
Last Updated
June 10, 2023
Sponsor
Jin Cheol Kim
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1. Study Identification

Unique Protocol Identification Number
NCT05913102
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jin Cheol Kim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pigmentation, Pigmentation Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
parallel assignment split lesion study
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental
Arm Type
Experimental
Arm Description
administer PDLLA
Arm Title
active comparator
Arm Type
Active Comparator
Arm Description
administer saline
Intervention Type
Drug
Intervention Name(s)
PDLLA
Intervention Description
Administer PDLLA/saline every 2 weeks for 2.5 months
Primary Outcome Measure Information:
Title
change of lightness value
Description
change of lightness value by a chromometer
Time Frame
Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.
Secondary Outcome Measure Information:
Title
patinent global assessment for skin condition
Description
patinent global assessment for skin condition by a self-questionnaire
Time Frame
Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.
Title
investigator global assessment score for pigmentation
Description
investigator global assessment score for pigmentation by clinical photos
Time Frame
Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.
Title
Fitzpatrick wrinkle and elastosis scale
Description
Fitzpatrick wrinkle and elastosis scale by clinical photos
Time Frame
Photos will be taken before each treatment and 4,8,12 weeks after the final treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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