Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea (NCT07667972) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea
China200 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range
20 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Pigment Area and Severity Score at Month 6
Timeframe: Baseline to Month 6
2
Change From Baseline in Erythema Score at Month 6
Timeframe: Baseline to Month 6
Trial details
NCT IDNCT07667972
SponsorXiangya Hospital of Central South University
. 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.
Exclusion criteria
. 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.