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NCT Number: NCT07068061

PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

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.

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Key information

Conditions

Wrinkles Anti Aging Face-lift

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

PDO suture

Device

A biodegradable polymer used in dissolvable sutures and lifting threads, stimulating collagen production as it degrades.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Further evaluation of improvement of the mid-face appearance.

    Time frame: up to 35 weeks

    Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).

  2. Self-evaluation of improvement of the mid-face appearance by the Subject.

    Time frame: up to 35 weeks

    Proportion of subjects with any improvement compared to baseline, as assessed by the Subject.

  3. Number of (S)AEs.

    Time frame: up to 35 weeks

    Number of (S)AEs evaluated by the subject using patient diary

Study contacts

Contact information is provided by the study sponsor or research team.

Pure Clinical Sp. z o.o

CONTACT

[email protected]

+48739262242

Sponsors and collaborators

Lead sponsor

21 Century Medical Co., Ltd.

Industry

Registry information

Official study title

Evaluation of the Performance and Safety of Polydioxanone Suture (PDO) "Bio Meyisun" for the Temporary Correction of the Mid-face Area.

Acronym: PER-SAF_PDOS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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