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Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Primary endpoint(s) modified
    • Secondary endpoints revised (7)
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07667972
Lead Sponsor Xiangya Hospital of Central South University
Conditions
(from sponsor)		 Melasma, Rosacea, Periorbital Hyperpigmentation, Melanosis, Lichen Planus Pigmentosus
Related terms Melanosis, Rosacea
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov