Non-Surgical Rhinoplasty Using PDO Threads

Nasal Defect Clinical Trial

Official title:

Non-Surgical Rhinoplasty Using Polydioxanone Threads

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04769427
• Other study ID #: PDO-122020
• Status: Completed
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: October 10, 2021

Study information

• Verified date: October 2021
• Source: DeNova Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 10, 2021
• Est. primary completion date: June 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nasal Defect

Intervention

Device:
• PDO max threads
To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale)

Locations

Country	Name	City	State
United States	DeNova Research	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
DeNova Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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