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Comperative efficacy and safety of a microneedle patch for the improvement of the nasolabial fold

Comperative efficacy and safety of a microneedle patch for the improvement of the nasolabial fold : A split-face design double blind study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20231008001
Enrollment
40
Registered
2023-10-08
Start date
2023-06-01
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

Facial wrinkle in the nasolabial folds area skin aging, nasolabial fold, rejuvenation, microneedle patch, microneedling

Interventions

The microneedle (MN) array was fabricated on the fabric substrate via the photo-polymerization technique. Each microneedle was designed with a pyramidal shape. The average height (h) of microneedles i
Active Comparator Device,Active Comparator Device
Microneedle patch,Microneedle patch

Sponsors

Thammasat University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Female patient age between 20-60 years old 2. Mild to moderate nasolabial folds according to the Merz Aesthetics Scale

Exclusion criteria

Exclusion criteria: 1. Patient refuses to participate in the study 2. Pregnancy or lactation 3. History of energy base device treatment within 1 year 4. History of laser therapy within 6 months 5. History of chemical peeling within 1 month 6. History of mesotherapy injection at nasolabial folds within 1 month 7. History of Botox or filler injection at nasolabial folds within 1 year 8. History of taking antiplatelet and anticoagulants within 1 month 9. A current or prior history of infectious skin disease 10. A current or prior history of eczematous dermatitis on the face 11. A current or prior history of using immunosuppressive therapy 12. A current or prior history of allergy or hypersensitivity to polymethylmethacrylate (PMMA) and the monomer plastic 13. A current or prior history of collagen supplement 14. Other underlying that cosmetic affect their health condition

Design outcomes

Primary

MeasureTime frame
Severity of Nasolabial folds at 2 weeks interval for a total of 12 weeks Merz Aesthetics Scale

Secondary

MeasureTime frame
Pain score At 2 weeks interval for a total of 12 weeks visual analog scale ,Skin elasticity At 2 weeks interval for a total of 12 weeks Cutometer,Skin roughness At 2 weeks interval for a total of 12 weeks Antera 3D,Participants satisfaction At 2 weeks interval for a total of 12 weeks Participants satisfaction score

Countries

Thailand

Contacts

Public ContactJitlada Meephansan

Chulabhorn International College of Medicine, Thammasat University

kae_mdcu@yahoo.com0972468497

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026