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

Nanjing Medical University

Status: Completed

Conditions: Solar Lentigo

Treatments: Device: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)

Study type: Observational

Funder types: Other

Identifiers

NCT06288607

2023-SR-708

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period;
2. those who are allergic to medical condensation gel;
3. those with photosensitive diseases, immune deficiencies, or those who are taking immunosuppressants;
4. those with scar physique;
5. those with inflammatory or infectious skin diseases;
6. those who have systemically used retinoic acid in the last six months or topically applied retinoic acid drugs in the last three months, or have a history of sun exposure in the four weeks prior to treatment;
7. those who have undergone high-intensity focused ultrasound treatment within the last six months;

Trial design

21 participants in 1 patient group

Patients

Description:

Patients with solar lentigo

Treatment:

Device: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)