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
Phase 4
Active, not recruiting
- Conditions
- Melasma on both sides of the facechlorasmamelasmamask of pregnancyHIFUHIF
- Registration Number
- TCTR20180424005
- Lead Sponsor
- Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 25
Inclusion Criteria
-bilateral mixed type melasma on face
-able to comply with treatment regulations
-able to attend every appointment assigned
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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