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Can sound waves clear up skin? new trial tests ultrasound for pigment and rosacea

NCT ID NCT07667972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

20 to 60 years

Sex

Anyone

Healthy volunteers

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

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

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410083, China

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Other studies related to the condition(s) this trial covers.