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

• Sponsor: Jin Cheol Kim (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05913102
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15.1
• Patients Per Site Per Month: 2.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pigmentation; Pigmentation Disorder	Drug: PDLLA	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: parallel assignment split lesion studyparallel assignment split lesion study
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
• Actual Study Start Date: Sep 28, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ajou University Hospital	Suwon		Korea, Republic of

Sponsors and Collaborators

• Jin Cheol Kim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin Cheol Kim, Principal investigator, research assistant professor, Ajou University School of Medicine
• ClinicalTrials.gov Identifier: NCT05913102
• Other Study ID Numbers: AJOUIRB-INT-2021-630
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pigmentation Disorders

Study Results

No Results Posted as of Jun 22, 2023