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Efficacy and safety of using of sharp needle and cannula injection of polynucleotide in the treatment for facial Rejuvenation in Thailand, a split face analysis

Efficacy and safety of using of sharp needle and cannula injection of polynucleotide in the treatment for facial Rejuvenation in Thailand, a split face analysis

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250207003
Enrollment
30
Registered
2025-02-07
Start date
2024-12-27
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

participants with sign of photoaging Polynucleotide, cannula injection, sharp needle injection, facial rejuvenation

Interventions

Patient face was injected with cannula needle at this random side of face,Patient face was injected with sharp needle at this random side of face
Experimental Device,Experimental Device

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Age from 30-55 years, both male and female. 2. Assessed by a specialist dermatologic surgeon with the Glogau classification of photoaging indicating a moderate level or higher 3. Thai of Asian descent 4. Participants who consent to join the project voluntarily and agree to receive injections of polynucleotides with the quantity and at the positions specified in the research protocol.

Exclusion criteria

Exclusion criteria: 1. Pregnant women and those breastfeeding 2. Participants with inflammatory skin rashes (dermatitis), wounds, or infected skin on the face. 3. Participants who have had facial and/or neck lifting procedures within 6 months prior to joining the research project. 4. Participants with severe chronic diseases. 5. Participants who have had injections of fillers, thread lifting, or polynucleotides within 12 months before joining the research project. 6. Participants who have had botulinum toxin injections within 6 months before joining the research project. 7. Participants with hypertrophic scars. 8. Participants with a diagnosed mental disorder by a psychiatrist. 9. Participants who do not consent to having photographs taken for treatment assessment. 10. Participants with a history of taking immunosuppressive medications such as steroids, undergoing chemotherapy, or taking medications affecting blood clotting, such as aspirin. 11. Participants with a history of allergy to local anesthetics or polynucleotides. 12. Participants with a history of blood clotting disorders.

Design outcomes

Primary

MeasureTime frame
Wrinkle baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment antera,Texture baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment antera,Patient improvement score baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment global aesthetic improvement scale

Secondary

MeasureTime frame
volume change baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment vector,volume change baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment quantificare,skin elasticity baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment cutometer,melanin baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment mexameter,ITA baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment colorimeter,sebum baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment sebumeter,hydration baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment corneometer,physician assessment score baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment photo,pain score baseline, 1 month after 1st treatment, 1 month after 2nd treatment visual analog scale,adverse event baseline, 1 month after 1st treatment, 1 month after 2nd treatment, 1 month after complete treatment, 3- , 6- , 9- and 12- months after complete treatment note

Countries

Thailand

Contacts

Public ContactRungsima Wanitphakdeedecha

Faculty of Medicine Siriraj Hospital, Mahidol University

rungsima.wan@mahidol.ac.th664192667

Outcome results

None listed

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