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

Pigmentation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05913102
• Other study ID #: AJOUIRB-INT-2021-630
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 28, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Ajou University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pigmentation
• Pigmentation Disorder
• Pigmentation Disorders

Intervention

Drug:
• PDLLA
Administer PDLLA/saline every 2 weeks for 2.5 months

Locations

Country	Name	City	State
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Jin Cheol Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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