Non-Surgical Rhinoplasty Using PDO Threads

• Sponsor: DeNova Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT04769427
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 8.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Nasal Defect	Device: PDO max threads	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Non-Surgical Rhinoplasty Using Polydioxanone Threads
• Actual Study Start Date: Jan 20, 2021
• Actual Primary Completion Date: Jun 9, 2021
• Actual Study Completion Date: Oct 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DeNova Research	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• DeNova Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DeNova Research
• ClinicalTrials.gov Identifier: NCT04769427
• Other Study ID Numbers: PDO-122020
• First Posted: Feb 24, 2021
• Last Update Posted: Oct 12, 2021
• Last Verified: Oct 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Oct 12, 2021