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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active Microfocused Ultrasound - Rosacea Cohort
Participants with rosacea will receive active microfocused ultrasound treatment once monthly for 6 months.
干预措施: Microfocused Ultrasound Treatment (Device)
Active Microfocused Ultrasound - Pigmentary Disease Cohort
Participants with facial pigmentary diseases will receive active microfocused ultrasound treatment once monthly for 6 months.
干预措施: Microfocused Ultrasound Treatment (Device)
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.
干预措施: Sham Microfocused Ultrasound Stimulation (Device)
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.
干预措施: Sham Microfocused Ultrasound Stimulation (Device)
结局指标
主要结局
Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6
时间窗: Baseline to 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.
Change From Baseline in Clinician's Erythema Assessment Score at Month 6
时间窗: Baseline to 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.
次要结局
- 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 Dermatology Life Quality Index Score(Baseline to Months 6 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)
- Change From Baseline in Patient Health Questionnaire-9 Score(Baseline to Months 6 and 12)
研究者
Jian dan
Professor
Xiangya Hospital of Central South University