An interventional study of Microfocused Ultrasound Treatment and Sham Microfocused Ultrasound Stimulation in Melasma, Rosacea and Periorbital Hyperpigmentation, sponsored by Xiangya Hospital of Central South University. Active, not recruiting at 1 site in China. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Xiangya Hospital of Central South University · Not applicable, Interventional, and Treatment
This clinical study will evaluate the efficacy and safety of microfocused ultrasound treatment in patients with facial pigmentary diseases and rosacea.
The study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomly assigned to receive either active microfocused ultrasound treatment or sham stimulation. Sham stimulation will follow the same treatment procedure as active treatment but will not deliver effective therapeutic ultrasound energy.
Participants will receive one treatment session per month for 6 months and will be followed for up to 12 months. The study will assess changes in clinical severity scores, digital skin imaging parameters, patient-reported symptoms, quality of life, and safety outcomes, including adverse events.
This is a prospective, randomized, sham-controlled, assessor-blinded, parallel-group clinical study designed to evaluate the efficacy and safety of microfocused ultrasound in patients with facial pigmentary diseases and rosacea.
The study consists of two independent disease cohorts. The facial pigmentary disease cohort will include participants with eligible facial pigmentary disorders, such as melasma, periorbital hyperpigmentation, melanosis, and lichen planus pigmentosus. The rosacea cohort will include participants who meet the diagnostic criteria for rosacea. Each cohort will be randomized separately in a 1:1 ratio to either the active microfocused ultrasound group or the sham stimulation control group.
Participants assigned to the active treatment group will receive microfocused ultrasound treatment once monthly for 6 months. The planned treatment parameters include a power range of 3.76 to 5.12 W and a frequency of 8 Hz, with each session stopped after the preset treatment endpoint is reached. Participants assigned to the sham stimulation group will undergo the same procedure, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic energy.
Efficacy assessments will include investigator-assessed clinical severity scores, patient-reported outcome measures, VISIA digital skin analysis, dermatology-related quality of life assessment, and psychological symptom assessment. Safety will be evaluated through physical examination, vital signs, and monitoring of adverse events and serious adverse events throughout the study.
An exploratory tissue sample substudy may be conducted in participants who voluntarily provide additional informed consent. This substudy is exploratory and will not affect participation in the main study or the primary efficacy analysis.
170 studies on the registry are indexed under Melanosis; 46 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 157 interventional studies indexed under Melanosis.
Browse Melanosis studies →Xiangya Hospital of Central South University is the lead sponsor of 174 studies on the registry; 77 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with facial pigmentary diseases will receive active microfocused ultrasound treatment once monthly for 6 months.
Device: Microfocused Ultrasound Treatment
Participants with facial pigmentary diseases will receive sham stimulation once monthly for 6 months. The sham procedure will follow the same treatment process as active treatment, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic ultrasound energy.
Device: Sham Microfocused Ultrasound Stimulation
Participants with rosacea will receive active microfocused ultrasound treatment once monthly for 6 months.
Device: Microfocused Ultrasound Treatment
Participants with rosacea will receive sham stimulation once monthly for 6 months. The sham procedure will follow the same treatment process as active treatment, including use of ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic ultrasound energy.
Device: Sham Microfocused Ultrasound Stimulation
Active microfocused ultrasound treatment will be administered using an ultrasound therapy device. Treatment parameters are planned as power 3.76 to 5.12 W and frequency 8 Hz. Each treatment session will stop when the preset treatment endpoint. Treatment will be performed once monthly for 6 months.
Sham stimulation will use the same procedure as active microfocused ultrasound treatment, including ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but will not deliver effective therapeutic ultrasound energy.
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6
Change from baseline to Month 6 in the Melasma Area and Severity Index (MASI)-based pigment area and severity score in the pigmentary disease cohort. The score assesses lesion area, darkness, and homogeneity across facial regions. Total scores range from 0 to 48, with higher scores indicating more severe pigmentation.
Time frame: Baseline to Month 6
Change From Baseline in Clinician's Erythema Assessment Score at Month 6
Change from baseline to Month 6 in the Clinician's Erythema Assessment (CEA) score in the rosacea cohort. The CEA score ranges from 0 to 4, where 0 indicates clear or no erythema and 4 indicates severe erythema. Higher scores indicate more severe erythema.
Time frame: Baseline to Month 6
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Months 2, 4, and 12
Change from baseline to Months 2, 4, and 12 in the Melasma Area and Severity Index (MASI)-based pigment area and severity score in the pigmentary disease cohort. The score assesses lesion area, darkness, and homogeneity across facial regions. Total scores range from 0 to 48, with higher scores indicating more severe pigmentation.
Time frame: Baseline to Months 2, 4, and 12
Change From Baseline in Melasma Quality of Life Scale Score
Change from baseline in the Melasma Quality of Life Scale score in the pigmentary disease cohort. The scale contains 10 items scored from 1 to 7. Total scores range from 10 to 70, with higher scores indicating worse health-related quality of life and greater disease impact.
Time frame: Baseline to Months 6 and 12
Change From Baseline in Clinician's Erythema Assessment Score at Months 2, 4, and 12
Change from baseline to Months 2, 4, and 12 in the Clinician's Erythema Assessment (CEA) score in the rosacea cohort. The CEA score ranges from 0 to 4, where 0 indicates clear or no erythema and 4 indicates severe erythema. Higher scores indicate more severe erythema.
Time frame: Baseline to Months 2, 4, and 12
Change From Baseline in Patient-Assessed Flushing Severity Score in the Rosacea Cohort
Change from baseline in patient-assessed flushing severity score in the rosacea cohort. Flushing is assessed using the rosacea clinical study patient assessment form. Scores range from 0 to 4, where 0 indicates none and 4 indicates always present. Higher scores indicate more frequent or more severe flushing.
Time frame: Baseline to Months 6 and 12
Change From Baseline in Patient- and Investigator-Assessed Rosacea Clinical Symptom Severity Scores
Change from baseline in patient- and investigator-assessed rosacea clinical symptom severity scores. Patient-assessed symptoms are evaluated using the rosacea clinical study patient assessment form, and investigator-assessed signs are evaluated using the rosacea clinical study investigator assessment form. Each item is scored from 0 to 4. For patient-assessed items, 0 indicates none and 4 indicates always present. For investigator-assessed items, 0 indicates clear or none and 4 indicates severe. Higher scores indicate more severe rosacea symptoms or signs.
Time frame: Baseline to Months 6 and 12
Change From Baseline in Dermatology Life Quality Index Score
Change from baseline in the Dermatology Life Quality Index (DLQI) score. The DLQI is a 10-item questionnaire assessing dermatology-related quality of life. Total scores range from 0 to 30, with higher scores indicating greater impairment in quality of life.
Time frame: Baseline to Months 6 and 12
Change From Baseline in Patient Health Questionnaire-9 Score
Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) score. The PHQ-9 contains 9 items, each scored from 0 to 3. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: Baseline to Months 6 and 12
Incidence of Adverse Events and Serious Adverse Events
Incidence of adverse events, serious adverse events, and treatment-related local reactions, including facial numbness and skin pain.
Time frame: Baseline through Month 12
Plan to share: No — Individual participant data will not be publicly shared due to participant privacy protection, the sensitive nature of facial images and clinical dermatology data, and institutional data management requirements. De-identified aggregate results may be reported in scientific publications.
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jul 2026, 9 months after the start.
Of 33 non-industry interventional studies with no phase under Melanosis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 9 months is close to that.
Counting every sponsor, half of 53 studies reached it within 9 months; a quarter within 5 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Xiangya Hospital of Central South University →