Non-Surgical Rhinoplasty Using PDO Threads

DeNova Research

Status: Completed

Conditions: Nasal Defect

Treatments: Device: PDO max threads

Study type: Interventional

Funder types: Other

Identifiers

NCT04769427

PDO-122020

Details and patient eligibility

About

To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical revision rhinoplasty on first impressions and quality of life (FACE-Q scale) in 10 patients who desire further changes to their nasal tip and/or nasal dorsum

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males and females of ages 18 and above.
2. Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit.

Exclusion criteria

1. Males and females below age of 18.
2. Subjects who have had previous surgery, filler injections, or other cosmetic treatments to the nose within the last 12 months.
3. Patients with any prior nasal implants
4. Subjects who are pregnant or nursing.
5. Subjects with a known allergy or sensitivity to any component of the study ingredients.
6. Any history of bleeding disorders (iatrogenic or otherwise). This includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks.
7. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks.
8. Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose
9. Subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

PDO Max thread injection to nose

Experimental group

Treatment:

Device: PDO max threads