Health TrialsbyHealthPanel

PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

ConditionsWrinklesAnti AgingFace-lift
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
Sponsor21 Century Medical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • PDO suture

    Device

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Interventional armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The assessment of improvement in mid-face appearance.

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

Time frame
up to 24 weeks

Secondary outcomes

1

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).

Time frame
up to 35 weeks
2

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.

Time frame
up to 35 weeks
3

Number of (S)AEs.

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

Time frame
up to 35 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

21 Century Medical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: