Nasal Defect
Conditions
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
Interventions
DEVICEPDO max threads
To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale)
Sponsors
DeNova Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Non -surgical rhinoplasty using PDO Max threads | 1 month | 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. |
Countries
United States
Outcome results
None listed