Non-Surgical Rhinoplasty Using PDO Threads

Not Applicable

Completed

• Conditions: Nasal Defect
• Interventions: Device: PDO max threads

• Registration Number: NCT04769427
• Lead Sponsor: DeNova Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-24
• Primary Completion: 2021-06-09
• Status Verified: 2021-10
• Study Completion: 2021-10-10
• Last Update Submitted: 2021-10-11
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PDO Max thread injection to nose	PDO max threads	-

Primary Outcome Measures

Name	Time	Method
Non -surgical rhinoplasty using PDO Max threads	1 month	The effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale). FACE-Q scales are rated from 1-4 with ratings closer to 4 as more favorable.

Secondary Outcome Measures

Name	Time	Method
Non -surgical rhinoplasty using PDO Max threads	1 month	The efficacy in reduction of nasal dorsum convexity, and improvement of tip rotation and projection as measured on pre/post injection 2D photographs

Trial Locations

Locations (1)

DeNova Research; 🇺🇸 Chicago, Illinois, United States