Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea

A Prospective, Randomized, Sham-controlled, Assessor-blinded, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Microfocused Ultrasound in Patients With Facial Pigmentary Diseases and Rosacea

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rosacea; Melanosis; Melasma; Lichen Planus Pigmentosus; Periorbital Hyperpigmentation
• Intervention / Treatment: Device: Microfocused Ultrasound Treatment; Device: Sham Microfocused Ultrasound Stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410083
      • Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female participants aged 20 to 60 years.
2. Diagnosed by the investigator as having facial pigmentary disease or rosacea eligible for this study.
3. Participants with rosacea must meet the diagnostic criteria of the Chinese Guideline for the Diagnosis and Treatment of Rosacea (2021 edition).
4. Participants with facial pigmentary diseases must be diagnosed by two dermatologists with associate senior professional title or above, based on clinical manifestations and, when necessary, auxiliary examinations such as Wood's lamp examination, dermoscopy, or skin histopathology. Eligible pigmentary diseases may include melasma, periorbital hyperpigmentation, melanosis, lichen planus pigmentosus, or other facial pigmentary diseases considered suitable for this study.
5. The skin lesions are suitable for microfocused ultrasound treatment and follow-up assessment.
6. Able to comply with study treatment, follow-up visits, photography, and related assessments during the study.
7. Able to understand the study procedures, voluntarily participate in the study, and sign written informed consent.

Exclusion Criteria:

1. Pregnant or lactating women, or women planning to become pregnant during the study period.
2. Known allergy to ultrasound coupling gel or any of its excipients.
3. Presence of other obvious active inflammatory skin diseases, infectious skin diseases, or other facial skin conditions that may affect efficacy evaluation, apart from the target disease of this study.
4. Use within 1 month before screening of topical medications or procedures that may affect study evaluation, including but not limited to corticosteroids, calcineurin inhibitors, depigmenting agents, or energy-based treatments.
5. Severe cardiac, hepatic, renal, or other important organ dysfunction, or other severe systemic diseases that, in the investigator's judgment, may affect the safety or efficacy evaluation of this study.
6. Participation in another clinical trial within 30 days before screening.
7. History of prolonged intense sun exposure within 1 month before screening, or expected inability to avoid significant sun exposure or outdoor exposure during the study period, which may affect study evaluation.
8. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Microfocused Ultrasound - Pigmentary Disease Cohort; Participants with facial pigmentary diseases will receive active microfocused ultrasound treatment once monthly for 6 months.	Device: Microfocused Ultrasound Treatment; 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 Comparator: Sham Stimulation - Pigmentary Disease Cohort; 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; 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.
Experimental: Active Microfocused Ultrasound - Rosacea Cohort; Participants with rosacea will receive active microfocused ultrasound treatment once monthly for 6 months.	Device: Microfocused Ultrasound Treatment; 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 Comparator: Sham Stimulation - Rosacea Cohort; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Baseline to Months 6 and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline through Month 12

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: June 20, 2026
• First Submitted That Met QC Criteria: June 20, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Rosacea; Focused ultrasound; Melasma; Pigmentation; Microfocused ultrasound; Facial skin disease
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hyperpigmentation; Skin and Connective Tissue Diseases; Melanosis; Rosacea
• Other Study ID Numbers: 202509103

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No