CompletedNot Applicable

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population

China21 participantsStarted 2023-11-16

Plain-language summary

This trial is a single-center, prospective study. The study proposes to recruit 20 patients with solar lentigo on both sides of the face. Patients are to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). oth sides of the face received treatment with identical parameters. The facial images are collected with dermoscope (DermLite DL4,3 Gen Inc., San Juan Capistrano, CA, USA), VISIA® (Canfield Company, USA) and a two-photon microscope (Transcend Vivoscope, China). For dermoscopy images, ImageJ software was then utilized to perform Lab\* conversion on both the lesional area and the surrounding non-lesional areas. Measurements of transepidermal water loss (TEWL) values, skin elasticity and related images at the same location, along with adverse events, physician and subjective global aesthetic improvement scale scores are recorded before and at week2, week 4, week6 and week8.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adults between 18 and 70 years old, regardless of gender;
. comply the clinical diagnostic criteria for solar lentigo on both sides of the face;
. patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form;

Exclusion criteria

. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period;
. those who are allergic to medical condensation gel;
. those with photosensitive diseases, immune deficiencies, or those who are taking immunosuppressants;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Lab* Values of Lesional Area Using Dermoscopy and ImageJ

Timeframe: week0, week2, week4, week6 and week8

Physician Global Aesthetic Improvement Scale Score

Timeframe: week2, week4, week6 and week8

Subjective Global Aesthetic Improvement Scale Score

Timeframe: week2, week4, week6 and week8

Transepidermal Water Loss (TEWL) Measurement of Lesional Area

Timeframe: week0, week2, week4, week6 and week8

Skin Elasticity Measurement of Lesional Area

Timeframe: week0, week2, week4, week6 and week8

Trial details

NCT IDNCT06288607

SponsorThe First Affiliated Hospital with Nanjing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-04

Results submitted2024-10-27

View on ClinicalTrials.gov More Solar Lentigo trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. adults between 18 and 70 years old, regardless of gender;
. comply the clinical diagnostic criteria for solar lentigo on both sides of the face;
. patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form;

Exclusion criteria

. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period;
. those who are allergic to medical condensation gel;
. those with photosensitive diseases, immune deficiencies, or those who are taking immunosuppressants;

What they're measuring

Lab* Values of Lesional Area Using Dermoscopy and ImageJ

Timeframe: week0, week2, week4, week6 and week8

Physician Global Aesthetic Improvement Scale Score

Timeframe: week2, week4, week6 and week8

Subjective Global Aesthetic Improvement Scale Score

Timeframe: week2, week4, week6 and week8

Transepidermal Water Loss (TEWL) Measurement of Lesional Area

Timeframe: week0, week2, week4, week6 and week8

Skin Elasticity Measurement of Lesional Area

Timeframe: week0, week2, week4, week6 and week8