Nasal DefectNCT04769427
Non-Surgical Rhinoplasty Using PDO Threads
A study testing PDO max threads in people with Nasal Defect, run by DeNova Research at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Defect
- What is being tested?
- PDO max threads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2021to 10 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-Surgical Rhinoplasty Using Polydioxanone 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
- Conditions
- Nasal Defect
- Being tested
- PDO max threads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDO max threadsDevice
To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale)
| Study group | Role | What they receive |
|---|---|---|
| PDO Max thread injection to nose | Experimental | Not described Receives: Device: PDO max threads |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (2)
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.
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start20 Jan 2021
- Primary completion9 Jun 2021
- Study completion10 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal DefectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- DeNova Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769427
- Sponsor's protocol ID
- PDO-122020
- Status last verified
- Oct 2021
- First submitted
- 20 Jan 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Surgical Rhinoplasty Using Polydioxanone Threads
- ClinicalTrials.gov ID
- NCT04769427
- Acronym / sponsor ID
- PDO-122020
- Conditions
- Nasal Defect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- DeNova ResearchUniversity, hospital or other
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 10 Oct 2021 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDO Max thread injection to nose | Experimental | Device: PDO max threads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PDO max threadsTo determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale) | Device | PDO Max thread injection to nose |
Primary outcome
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.
2 secondary outcomes
Non -surgical rhinoplasty using PDO Max threads
Time frame: 1 month
Non -surgical rhinoplasty using PDO Max threads
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
Related trials for Nasal Defect
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Full-Thickness Skin Graft Reconstruction of Nasal and Auricular Surgical Defects
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDO max threads in people with Nasal Defect, run by DeNova Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non -surgical rhinoplasty using PDO Max threads (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021; AzTrials last refreshed its copy on 28 Oct 2026.