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A Study of Efficacy and Safety of High-Intensity Focused Ultrasound for the Treatment of Melasma in Asians: A Single-Blind, Randomized, Split-face Pilot Study

A Study of Efficacy and Safety of High-Intensity Focused Ultrasound for the Treatment of Melasma in Asians: A Single-Blind, Randomized, Split-face Pilot Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180424005
Enrollment
Unknown
Registered
2018-04-24
Start date
2017-01-03
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

Melasma on both sides of the face chlorasma melasma mask of pregnancy HIFU

Interventions

One side of the face was randomly assigned to be treated by HIFU. Treatment was performed with 1.5 mm&#45
transducer&#44
fluence 0.2 J/cm2 for consecutive 3 sessions including at baseline&#44
at the 4th week&#44
and 8th week.,Another side of the face was randomly assigned to receive no treatment for comparison purpose.
Experimental Device,No Intervention No treatment
high intensity focused ultrasound (HIFU),Placebo

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: -bilateral mixed type melasma on face -able to comply with treatment regulations -able to attend every appointment assigned

Exclusion criteria

Exclusion criteria: -allergic to topical hydroquinone -being pregnant or lactating woman -currently/previously having skin cancers -having a history of keloid/hypertrophic scars -having autoimmune diseases -active acne vulgaris on face -having/had oral contraceptive pills or hormone replacement therapy within 1 year -used topical whitening within 3 months -underwent laser treatment within 6 months -had filler injection on experimental sites within 1 year

Design outcomes

Primary

MeasureTime frame
Relative lightness index Baseline and every 4 weeks after treatment (a total of 6 visits) At each visit, luminance scores were obtained from lesions and were subtracted by normal skin

Secondary

MeasureTime frame
modified melasma area and severity index (mMASI) Baseline and every 4 weeks after treatment (a total of 6 visits) Assessed by dermatologists,Improvement score 4th visit (16 weeks after treatment) 5-point scale was rated by patients,Satisfaction score 4th visit (16 weeks after treatment) visual analogue scale was rated by patients

Contacts

Public ContactWimolsiri Iamsumang

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital

wimolpahn@gmail.com662011166

Outcome results

None listed

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