PigmentationNCT05913102
A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
A study testing PDLLA in people with Pigmentation and Pigmentation Disorder, run by Jin Cheol Kim at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pigmentation, Pigmentation Disorder
- What is being tested?
- PDLLA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Sep 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- PDLLA
- Medical subject headings
- Pigmentation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDLLADrug
Administer PDLLA/saline every 2 weeks for 2.5 months
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | administer PDLLA Receives: Drug: PDLLA |
| active comparator | Active comparator | administer saline Receives: Drug: PDLLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of lightness value
change of lightness value by a chromometer
Measured: Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.
Secondary outcomes (3)
patinent global assessment for skin condition
patinent global assessment for skin condition by a self-questionnaire
Measured: 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
Measured: 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
Measured: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start28 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- parallel assignment split lesion study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jin Cheol Kim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Cheol Kim, Ajou University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05913102
- Sponsor's protocol ID
- AJOUIRB-INT-2021-630
- Status last verified
- Jun 2023
- First submitted
- 10 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Split-face, Randomized Study of the Poly-D, L Lactic Acid (PDLLA) for Photoaged Skin
- ClinicalTrials.gov ID
- NCT05913102
- Acronym / sponsor ID
- AJOUIRB-INT-2021-630
- Conditions
- Pigmentation, Pigmentation Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Jin Cheol KimUniversity, hospital or other
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- parallel assignment split lesion study
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Drug: PDLLAadminister PDLLA |
| active comparator | Active comparator | Drug: PDLLAadminister saline |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDLLAAdminister PDLLA/saline every 2 weeks for 2.5 months | Drug | active comparator, experimental |
Primary outcome
change of lightness value
Time frame: Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.
change of lightness value by a chromometer
3 secondary outcomes
patinent global assessment for skin condition
Time frame: Questionnaire will be taken before treatment and 4,8,12 weeks after last treatment.
investigator global assessment score for pigmentation
Time frame: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment.
Fitzpatrick wrinkle and elastosis scale
Time frame: Photos will be taken before each treatment and 4,8,12 weeks after the final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDLLA in people with Pigmentation and Pigmentation Disorder, run by Jin Cheol Kim at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of lightness value (time frame: Chromometer will be taken before treatment and 4,8,12 weeks after last treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.