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The study to evaluate the efficacy and safety of multiple bidirectional newton cog polydioxanone threads for nose shaping

The study to evaluate the efficacy and safety of multiple bidirectional newton cog polydioxanone threads for nose shaping

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251222003
Enrollment
25
Registered
2025-12-22
Start date
2023-08-28
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-linear nasal dorsum flat nasal tip thread lifting nose shaping

Interventions

Multiple bidirectional Newton cog polydioxanone (PDO) threads will be used for nasal shaping and applied to both the nasal dorsum and columella. Local anesthesia will be administered prior to the proc
Experimental Device

Sponsors

Faculty of Medicine Siriraj Hospital, Mahidol University, Thailand
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Participants aged 25 to 60 years, of both males and females. 2. Participants without indications for rhinoplasty, including those with a history of nasal trauma or congenital nasal deformities. 3. Participants with non linear nasal dorsum or a flat nasal tip, defined by drawing a reference line from the nasal tip through the lower lip to the chin, where the nasal tip lies below this imaginary line.

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding women 2. Participants with a history of prior nasal surgery. 3. Participants with underlying medical conditions, including platelet disorders, coagulation abnormalities, anemia, liver disease, malignancy, or autoimmune diseases. 4. Participants who smoke or have a history of heavy alcohol consumption. 5. Participants with dermatitis, open wounds, or skin infections in the nasal or intranasal area. 6. Participants with a history of allergy to local anesthetics, penicillins, or chloramphenicol. 7. Participants with a history of hormonal therapy, injectable or oral contraceptives, or regular use of NSAIDs. 8. Participants receiving medications that affect platelet function or blood coagulation, such as warfarin, direct oral anticoagulants (DOACs), or antiplatelet agents. 9. Participants who have received facial filler injections or botulinum toxin within 6 months prior to study enrollment. 10. Participants who have undergone facial lifting or tightening procedures within 6 months prior to study enrollment. 11. Participants with a history of keloid or hypertrophic scarring. 12. Participants with a psychiatric disorder diagnosed by a psychiatrist. 13. Participants who do not consent to facial photography for treatment evaluation.

Design outcomes

Primary

MeasureTime frame
Columella Labial Angle baseline, immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Vectra,Columella height to Alar width ratio baseline, immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Vectra,Nasofrontal Angle baseline, immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Vectra,Nasomental Angle baseline, immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Vectra,Tip projection ratio baseline, immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Vectra,Nasofacial Angle baseline, immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Vectra

Secondary

MeasureTime frame
Pain score at treatment Visual analog scale,Safety immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Adverse event,Participants improvement scale immediate after treatment, 1 week, 1 month, 3 months, and 6 months post-treatment Quartile scale

Countries

Thailand

Contacts

Public ContactThanya Techapichetvanich

Faculty of Medicine Siriraj Hospital, Mahidol University

thanya.tec@gmail.com024194333

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026