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

NCT06288607 | Completed Results DMC

• 1 other identifier: 2023-SR-708
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Lab* Values of Lesional Area Using Dermoscopy and ImageJ

  Before treatment, one point on each side of every patient was selected for measurement. Follow-up measurements were taken at the same locations after treatment, and comparisons were made between the pre- and post-treatment values on the same side. This outcome measure involves the assessment of lesional areas in dermoscopy images, with the Lab\* conversion of pigmentation intensity performed using ImageJ software. L\* represents the lightness (brightness) of the lesion, where higher L\* values indicate lighter lesions (improvement), ranging from 0 to 100. a\* and b\* represent the chromatic components (red-green and yellow-blue), both ranging from -128 to +127. Lower values in these components indicate lighter pigmentation, while higher values suggest darker lesions.

  week0, week2, week4, week6 and week8

• Physician Global Aesthetic Improvement Scale Score

  Two physicians independently assessed the overall unilateral condition of each patient at various follow-up time points after treatment, comparing the numerical values obtained after treatment for the same side. Both scores were averaged as the final data. The Physician Global Aesthetic Improvement Scale (PGAIS) is a 5-point scale used to rate the global aesthetic improvement in appearance compared to pretreatment, as judged by the investigator. The scale ranges from -1 (worsening) to 3 (very much improved). The higher score indicates the better improving effect.

  week2, week4, week6 and week8

• Subjective Global Aesthetic Improvement Scale Score

  At each follow-up time point after treatment, patients self-evaluated their unilateral overall condition and compared the numerical values of the same side before and after treatment. This process was repeated at every follow-up time point. The Subjective Global Aesthetic Improvement Scale (SGAIS) is a 5-point scale used to rate the global aesthetic improvement in appearance compared to pretreatment, as judged by the patients. The scale ranges from -1 (worsening) to 3 (very much improved). The higher score indicates the better improving effect.

  week2, week4, week6 and week8

• Transepidermal Water Loss (TEWL) Measurement of Lesional Area

  Before treatment, one point on each side of every patient was selected for measurement. Follow-up measurements were taken at the same locations after treatment, and comparisons were made between the pre- and post-treatment values on the same side. Transepidermal Water Loss (TEWL) TEWL can be used to assess a patient's skin barrier function, with lower values indicating stronger barrier function. This outcome measure involves the assessment of Transepidermal Water Loss (TEWL), which quantifies the amount of water evaporating through the skin. TEWL is a key indicator of skin barrier function and hydration levels. In this study, TEWL was measured using Tewameter Hex (Courage Khazaka Electronic GmbH) that records the rate of water loss through the skin in g/m²/h (grams per square meter per hour). Lower TEWL values (less water loss) suggest an improved skin barrier, which is typically the result of effective treatment and increased skin hydration.

  week0, week2, week4, week6 and week8

• Skin Elasticity Measurement of Lesional Area

  Before treatment, one point on each side of every patient was selected for measurement. Follow-up measurements were taken at the same locations after treatment, and comparisons were made between the pre- and post-treatment values on the same side. Skin elasticity was assessed using Cutometer Dual MPA580 (Courage Khazaka Electronic GmbH, Köln, Germany), which measures the skin's resistance to deformation and recovery after deformation. The R-value represents the ratio of skin's ability to resist deformation (stiffness) and its ability to return to its original shape (elasticity). Higher R-values (greater elasticity) suggest that the skin is more resilient and can return to its original shape after deformation, indicating healthy skin with good elasticity and tone.

  week0, week2, week4, week6 and week8

Study Arms (1)

Patients

Patients with solar lentigo

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

Interventions

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

Patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population for this trial consisted of adult males and females, aged 18 to 70 years, diagnosed with solar lentigo. The participants were recruited from The First Affiliated Hospital with Nanjing Medical University.

You may qualify if:

• 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;

You may not qualify if:

• 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;
• those with scar physique;
• those with inflammatory or infectious skin diseases;
• 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;
• those who have undergone high-intensity focused ultrasound treatment within the last six months;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

Results Point of Contact

• Title: Dr. Yang Xu
• Organization: The First Affiliated Hospital with Nanjing Medical University

yangxu@njmu.edu.cn

+8613851856794

Study Officials

• Yang Xu

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2024
• First Posted: March 1, 2024
• Study Start: November 16, 2023
• Primary Completion: May 4, 2024
• Study Completion: May 4, 2024
• Last Updated: June 5, 2025
• Results First Posted: June 5, 2025

Record last verified: 2025-05

Locations

CN (1)