Can sound waves clear up skin? new trial tests ultrasound for pigment and rosacea
NCT ID NCT07667972
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study tests whether microfocused ultrasound can safely improve facial pigmentary diseases (like melasma) and rosacea. Two hundred adults will be randomly assigned to receive either real ultrasound or a sham (fake) treatment once a month for six months. Researchers will track changes in skin color, redness, symptoms, and quality of life over a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Microfocused ultrasound (a device that uses ultrasound energy to treat skin)
- What this could lead to
- If it works, this could offer a new, non-invasive option to reduce facial pigmentation and redness in people with melasma, rosacea, or similar skin conditions.
- What could go wrong
- This is a mid-sized, early-stage trial with no phase designation. The sham control helps, but results may not apply to all skin types or severities. Side effects from ultrasound are possible, like temporary redness or swelling.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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20 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xiangya Hospital, Central South University
Changsha, Hunan, 410083, China
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Other studies related to the condition(s) this trial covers.
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- Can light therapy or special skincare tame rosacea redness? a trial puts them to the test