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Efficacy and safety of high-intensity focused ultrasound in static forehead wrinkles, a randomized, evaluator-blind comparative study

Efficacy and safety of high-intensity focused ultrasound in static forehead wrinkles, a randomized, evaluator-blind comparative study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190417009
Enrollment
Unknown
Registered
2019-04-17
Start date
2018-12-11
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

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Interventions

One side of the forehead is randomly selected to receive 3.0mm transducer of high intensity focused ultrasound for 100 lines after local anesthesia application.,One side of the forehead is randomly se
Active Comparator Device,Experimental Device
3.0mm transducer (single plane),3mm and 1.5mm transducer (dual plane)

Sponsors

Division of Dermatology, Department of medicine, Faculty of Medicine, Ramathibodi hospital
Lead Sponsor
Merz Healthcare (Thailand) Company Limited
Collaborator

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: -visible static forehead wrinkles of the same FLSGS on both sides of the forehead

Exclusion criteria

Exclusion criteria: - Having active infection on treatment site - Having open wound(s) on treatment site - Having scar(s) on treatment site - Having any cosmetic or surgical procedure on treatment site - Having metal implant on treatment site - Allergic to any anesthesic agents

Design outcomes

Primary

MeasureTime frame
forehead lines static grading scale (FLSGS) Evaluate at every visit Dermatologist evaluation of static forehead lines using visual-guided scale,Improvement score by dermatologist immediate after the treatment, 1, 3, and 6 months after treatment Dermatologist evaluation of improvement in skin laxity using visual analogue scale

Secondary

MeasureTime frame
Adverse events occured Evaluate on every visit Dermatologist evaluation and patients' feedback,Improvement score by patients immediate after the treatment, 1, 3, and 6 months after treatment Patient's evaluation of improvement in skin laxity using visual analogue scale

Contacts

Public ContactVasanop Vachiramon

Division of Dermatology, Department of medicine, Faculty of Medicine, Ramathibodi hospital

vasanop@gmail.com662011166

Outcome results

None listed

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