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A study of microfocused ultrasound for the prevention of melasma in Asians: a single-blinded, randomized, split-face study

A study of microfocused ultrasound for the prevention of melasma in Asians: a single-blinded, randomized, split-face study

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20221121005
Enrollment
25
Registered
2022-11-21
Start date
2021-07-15
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

Mixed type of melasma symmetrically distribute on both cheeks melasma microfocused ultrasound prevention recurrence relapse

Interventions

Microfocused ultrasound (Ultherapy, Merz Aesthetics, Germany) with 1.5-mm transducer, energy 0.18J per pulse, 50 treatment lines 1064nm Q-switched Nd:YAG laser (Revlite, Cynosure, United States) 8m
Experimental Device,Experimental Device
Microfocused ultrasound and low fluence Q switched Nd:YAG laser,Low fluence Q switched Nd:YAG laser alone

Sponsors

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Mixed type of melasma on both cheeks 2. Can participate the follow up visit

Exclusion criteria

Exclusion criteria: 1. Having active infection on treatment area 2. Having open wound on treatment area 3. Having any of serious medical or dermatologic conditions including autoimmune disorders, scars, or severe cystic acne on the face, a history of skin cancer, a history of photosensitive disorders, or allergy to topical anesthesia 4. Having a previous history of taking oral contraceptive pills or hormone replacement within 1 year 5. Having a previous history of the following treatments or procedure for melasma including topical whitening agents within 1 month, oral or injected treatment within 3 months, laser treatment , dermabrasion, peeling, radiofrequency or focused ultrasound within 6 months 6. Having a history of filler injection on treatment area within 1 year 7. Having a previous history of metal implant on treatment area 8. Pregnancy or lactation 9. Withdraw from study

Design outcomes

Primary

MeasureTime frame
recurrence of melasma at 57, 85, 113, 141, 169 days after the last treatment relative lightness index, melasma area and severity index

Secondary

MeasureTime frame
efficacy and safety of microfocused ultrasound at 57, 85, 113, 141, 169 days after the last treatment lightness index, melasma area and severity index, patient's report of adverse events

Countries

Thailand

Contacts

Public ContactVasanop Vachiramon

Faculty of Medicine Ramathibodi Hospital, Mahidol University

vasanop@gmail.com0946369165

Outcome results

None listed

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