Non-Surgical Rhinoplasty Using PDO Threads

Study Overview
=================
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

Official Title
-----------------
Non-Surgical Rhinoplasty Using Polydioxanone Threads

Conditions
-----------------
Nasal Defect

Intervention / Treatment
-----------------
* Device: PDO max threads


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females of ages 18 and above. Subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months. 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: Males and females below age of 18. Subjects who have had previous surgery, filler injections, or other cosmetic treatments to the nose within the last 12 months. Patients with any prior nasal implants Subjects who are pregnant or nursing. Subjects with a known allergy or sensitivity to any component of the study ingredients. 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. Anyone taking aspirin, ibuprofen, St. John's Wort, or high doses of Vitamin E supplements in the last 3 weeks. Subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDO Max thread injection to nose<br> | Device: PDO max threads<br>* To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non -surgical rhinoplasty using PDO Max threads | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non -surgical rhinoplasty using PDO Max threads | The effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on first impressions (using the first impression questionnaire). Questionnaire is rated from 1 to 10 with results closer to 10 as more favorable. | 1 month | 
| Non -surgical rhinoplasty using PDO Max threads | The efficacy in reduction of nasal dorsum convexity, and improvement of tip rotation and projection as measured on pre/post injection 2D photographs | 1 month |