WrinklesPER-SAF_PDOSNCT07068061
PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)
A study testing PDO suture in people with Wrinkles and Anti Aging, run by 21 Century Medical Co., Ltd..
Trial summary
This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrinkles, Anti Aging, Face-lift
- What is being tested?
- PDO suture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old with full legal capacity, male and female;
- Patients with ability to understand the proposed aesthetic correction and to understand and sign informed consent;
- Patients who are willing and able to comply with scheduled visits, aesthetic correction procedure and other trial procedures.
Who cannot join
- Pregnant or breast--feeding women;
- Patients currently participating in any other clinical investigation;
- Patients who have received a vaccine within 14 days prior to the baseline or plan to have vaccine within 14 days after the injection;
- Patients with a medical history of systemic diseases, including severe kidney, liver, heart and neurological disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Performance and Safety of Polydioxanone Suture (PDO) "Bio Meyisun" for the Temporary Correction of the Mid-face Area.
This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.
- Conditions
- Wrinkles, Anti Aging, Face-lift
- Being tested
- PDO suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDO sutureDevice
A biodegradable polymer used in dissolvable sutures and lifting threads, stimulating collagen production as it degrades.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | The procedure will start with skin cleansing using an antiseptic and careful marking of entry and exit points for thread placement. Aesthetic cream and local anaesthesia will be applied to enhance patient comfort before inserting PDO barbed threads into the subdermal layer using a cannula. The threads will be adjusted to create a natural-looking lift, followed by manual lifting to anchor them securely within the tissue. Finally, any excess thread will be trimmed, the area massaged for proper positioning, and the skin cleaned again to maintain sterility. Receives: Device: PDO suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The assessment of improvement in mid-face appearance.
Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).
Measured: up to 24 weeks
Secondary outcomes (3)
Further evaluation of improvement of the mid-face appearance.
Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).
Measured: up to 35 weeks
Self-evaluation of improvement of the mid-face appearance by the Subject.
Proportion of subjects with any improvement compared to baseline, as assessed by the Subject.
Measured: up to 35 weeks
Number of (S)AEs.
Number of (S)AEs evaluated by the subject using patient diary
Measured: up to 35 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WrinklesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 21 Century Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068061
- Sponsor's protocol ID
- PC-MD-CIP-004
- Acronym
- PER-SAF_PDOS
- Status last verified
- Jul 2025
- First submitted
- 27 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of Polydioxanone Suture (PDO) "Bio Meyisun" for the Temporary Correction of the Mid-face Area.
- ClinicalTrials.gov ID
- NCT07068061
- Acronym / sponsor ID
- PER-SAF_PDOS / PC-MD-CIP-004
- Conditions
- Wrinkles, Anti Aging, Face-lift
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- 21 Century Medical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 16 Jul 2025 (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.
This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: PDO sutureThe procedure will start with skin cleansing using an antiseptic and careful marking of entry and exit points for thread placement. Aesthetic cream and local anaesthesia will be applied to enhance patient comfort before inserting PDO barbed threads into the subdermal layer using a cannula. The threads will be adjusted to create a natural-looking lift, followed by manual lifting to anchor them securely within the tissue. Finally, any excess thread will be trimmed, the area massaged for proper positioning, and the skin cleaned again to maintain sterility. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years old with full legal capacity, male and female;
- Patients with ability to understand the proposed aesthetic correction and to understand and sign informed consent;
- Patients who are willing and able to comply with scheduled visits, aesthetic correction procedure and other trial procedures.
Key exclusion criteria (4 listed)
- Pregnant or breast--feeding women;
- Patients currently participating in any other clinical investigation;
- Patients who have received a vaccine within 14 days prior to the baseline or plan to have vaccine within 14 days after the injection;
- Patients with a medical history of systemic diseases, including severe kidney, liver, heart and neurological disorders.
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 |
|---|---|---|
| PDO sutureA biodegradable polymer used in dissolvable sutures and lifting threads, stimulating collagen production as it degrades. | Device | Interventional arm |
Primary outcome
The assessment of improvement in mid-face appearance.
Time frame: up to 24 weeks
Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).
3 secondary outcomes
Further evaluation of improvement of the mid-face appearance.
Time frame: up to 35 weeks
Self-evaluation of improvement of the mid-face appearance by the Subject.
Time frame: up to 35 weeks
Number of (S)AEs.
Time frame: up to 35 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Related trials for Wrinkles
Active, not recruiting
A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment
Wrinkle, Lax Skin
Not yet recruitingPhase 2
Can TrenibotulinumtoxinE Reverse OnabotulinumtoxinA Effect in Treating Lateral Canthal Lines?
Wrinkles and Rhytides
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Active, not recruiting
Clinical Feasibility Study to Evaluate the Safety and Performance of the Profound Matrix System
Skin Laxity, Wrinkle
Not yet recruiting
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Wrinkles, Midface Contour Deficiencies
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.
Questions about this trial
What is this clinical trial studying?
A study testing PDO suture in people with Wrinkles and Anti Aging, run by 21 Century Medical Co., Ltd..
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 4 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: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pure Clinical Sp. z o.o (+48739262242, MDsafety@pureclinical.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The assessment of improvement in mid-face appearance. (time frame: up to 24 weeks). 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 16 Jul 2025.