Active, not recruiting
Not applicable
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
Condition(s) studied
MelasmaRosaceaPeriorbital HyperpigmentationMelanosisLichen Planus Pigmentosus
Investigational drug(s) / intervention(s)
Microfocused Ultrasound TreatmentSham Microfocused Ultrasound Stimulation
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 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.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Change From Baseline in Melasma Area and Severity Index-Based Pigment Area and Severity Score at Month 6 — 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 — 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.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Xiangya Hospital, Central South University |
Changsha |
Hunan |
|
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