Clinical Trial

Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea

Active, Not Recruiting
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Record status
This record was last updated June 30, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-07-01
Trial Details
NCT Number NCT07667972
Lead Sponsor Xiangya Hospital of Central South University
Conditions Melasma, Rosacea, Periorbital Hyperpigmentation, Melanosis, Lichen Planus Pigmentosus
Enrollment 200 participants
Start Date 2025-10-01
Primary Completion 2026-07-01 (estimated)
Study Completion 2026-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-30