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

NCT ID: NCT06288607

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-16
• Study Completion Date: 2024-05-04

Brief 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.

Conditions

Solar Lentigo

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients

Patients with solar lentigo

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

Intervention Type: DEVICE

Before treatment, a 2-3mm thick medical condensation gel is evenly applied on the face. Patients are to be treated with two macro-focused handpieces with focal depths at 3.0 mm (D3.0) and 4.5 mm (D4.5) on both side. Following the treatment, local cooling with an ice pack was performed for 10 min to reduce redness and swelling. Patients were followed up at 2, 4, 6, and 8 weeks. Clinical images and non-invasive skin assessments were collected at baseline and during each visit.

Interventions

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

Before treatment, a 2-3mm thick medical condensation gel is evenly applied on the face. Patients are to be treated with two macro-focused handpieces with focal depths at 3.0 mm (D3.0) and 4.5 mm (D4.5) on both side. Following the treatment, local cooling with an ice pack was performed for 10 min to reduce redness and swelling. Patients were followed up at 2, 4, 6, and 8 weeks. Clinical images and non-invasive skin assessments were collected at baseline and during each visit.

Intervention Type: DEVICE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yang Xu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2023-SR-708

Identifier Type: -

Identifier Source: org_study_id