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OpenTrials
Completed

NCT Number: NCT04769427

Non-Surgical Rhinoplasty Using PDO Threads

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

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Key information

Conditions

Nasal Defect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

DeNova Research

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PDO max threads

Device

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

Primary outcomes

  1. Non -surgical rhinoplasty using PDO Max threads

    Time frame: 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 outcomes

  1. Non -surgical rhinoplasty using PDO Max threads

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

DeNova Research

Other

Registry information

Official study title

Non-Surgical Rhinoplasty Using Polydioxanone Threads

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 24, 2021
Registry last updated
Oct 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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