MedTrace Logo

Microfocused Ultrasound for Facial Pigmentary Diseases and Rosacea

NCT07667972 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-06-30

No results posted yet for this 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.

Conditions

  • Melasma
  • Rosacea
  • Periorbital Hyperpigmentation
  • Melanosis
  • Lichen Planus Pigmentosus

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-07-01
Completion
2026-09-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07667972 on ClinicalTrials.gov