Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea

NCT07667972 | Active Not Recruiting

• 1 other identifier: 202509103
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melasma; Rosacea; Periorbital Hyperpigmentation; Melanosis; Lichen Planus Pigmentosus

Keywords

Microfocused ultrasound; Focused ultrasound; Melasma; Rosacea; Pigmentation; Facial skin disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Months 2, 4, and 12

  Baseline to Months 2, 4, and 12

• Change From Baseline in Melasma Quality of Life Scale Score

  Baseline to Months 6 and 12

• Change From Baseline in Clinician's Erythema Assessment Score at Months 2, 4, and 12

  Baseline to Months 2, 4, and 12

• Change From Baseline in Patient-Assessed Flushing Severity Score in the Rosacea Cohort

  Baseline to Months 6 and 12

• Change From Baseline in Patient- and Investigator-Assessed Rosacea Clinical Symptom Severity Scores

  Baseline to Months 6 and 12

Other Outcomes (1)

• Incidence of Adverse Events and Serious Adverse Events

  Baseline through Month 12

Study Arms (4)

Active Microfocused Ultrasound - Pigmentary Disease Cohort

EXPERIMENTAL

Participants with facial pigmentary diseases will receive active microfocused ultrasound treatment once monthly for 6 months.

Device: Microfocused Ultrasound Treatment

Sham Stimulation - Pigmentary Disease Cohort

SHAM COMPARATOR

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

Active Microfocused Ultrasound - Rosacea Cohort

EXPERIMENTAL

Participants with rosacea will receive active microfocused ultrasound treatment once monthly for 6 months.

Device: Microfocused Ultrasound Treatment

Sham Stimulation - Rosacea Cohort

SHAM COMPARATOR

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

Interventions

Microfocused Ultrasound Treatment DEVICE

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.

Active Microfocused Ultrasound - Pigmentary Disease Cohort; Active Microfocused Ultrasound - Rosacea Cohort

Sham Microfocused Ultrasound Stimulation DEVICE

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.

Sham Stimulation - Pigmentary Disease Cohort; Sham Stimulation - Rosacea Cohort

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female participants aged 20 to 60 years.
• Diagnosed by the investigator as having facial pigmentary disease or rosacea eligible for this study.
• Participants with rosacea must meet the diagnostic criteria of the Chinese Guideline for the Diagnosis and Treatment of Rosacea (2021 edition).
• 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.
• The skin lesions are suitable for microfocused ultrasound treatment and follow-up assessment.
• Able to comply with study treatment, follow-up visits, photography, and related assessments during the study.
• Able to understand the study procedures, voluntarily participate in the study, and sign written informed consent.

You may not qualify if:

• Pregnant or lactating women, or women planning to become pregnant during the study period.
• Known allergy to ultrasound coupling gel or any of its excipients.
• 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.
• 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.
• 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.
• Participation in another clinical trial within 30 days before screening.
• 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.
• Any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital, Central South University

Changsha, Hunan, 410083, China

Location

MeSH Terms

Conditions

Melanosis; Rosacea

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be masked to treatment assignment. Sham stimulation will use the same treatment procedure as active microfocused ultrasound, including ultrasound coupling gel, probe contact, treatment environment, and treatment duration, but without delivery of effective therapeutic energy. Treatment operators cannot be masked because they perform either active or sham treatment, but they will not participate in efficacy assessment, image evaluation, or statistical analysis. Treatment assignments will be maintained through a central randomization system until unmasking according to the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study includes two independent disease cohorts: a facial pigmentary disease cohort and a rosacea cohort. Participants in each cohort will be randomized separately in a 1:1 ratio to receive either active microfocused ultrasound treatment or sham stimulation. The study uses a parallel-group design. Efficacy analyses will be conducted separately for the two disease cohorts.

Study Record Dates

• First Submitted: June 20, 2026
• First Posted: June 25, 2026
• Study Start: October 1, 2025
• Primary Completion: July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)