NCT06288607

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

Completed Results posted Last updated 5 June 2025

What this trial tests

trial testing High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) in Solar Lentigo in 21 participants. Completed in 4 May 2024.

Timeline

16 November 2023

Primary endpoint
4 May 2024

4 May 2024

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	21
Start date	16 November 2023
Primary completion	4 May 2024
Estimated completion	4 May 2024
Sites	1 location across China

Drugs / interventions tested

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

Conditions studied

• Solar Lentigo — all drugs for Solar Lentigo →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 70, any sex, with Solar Lentigo. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Lab* Values of Lesional Area Using Dermoscopy and ImageJ Primary · week0, week2, week4, week6 and week8

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 co

L* of left side at baseline

Group	Value	95% CI
All Study Participants	68.850	± 5.952

L* of left side at week2

Group	Value	95% CI
All Study Participants	72.103	± 8.324

L* of left side at week4

Group	Value	95% CI
All Study Participants	73.147	± 6.483

L* of left side at week6

Group	Value	95% CI
All Study Participants	72.633	± 5.007

L* of left side at week8

Group	Value	95% CI
All Study Participants	73.646	± 3.532

L* of right side at baseline

Group	Value	95% CI
All Study Participants	68.671	± 8.038

L* of right side at week2

Group	Value	95% CI
All Study Participants	71.433	± 8.643

L* of right side at week4

Group	Value	95% CI
All Study Participants	72.756	± 7.085

Physician Global Aesthetic Improvement Scale Score Primary · week2, week4, week6 and week8

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.

scores of left side at week2

Group	Value	95% CI
All Study Participants	0.800	± 0.510

scores of left side at week4

Group	Value	95% CI
All Study Participants	1.368	± 0.470

scores of left side at week6

Group	Value	95% CI
All Study Participants	1.850	± 0.477

scores of left side at week8

Group	Value	95% CI
All Study Participants	1.889	± 0.624

scores of right side at week2

Group	Value	95% CI
All Study Participants	0.900	± 0.436

scores of right side at week4

Group	Value	95% CI
All Study Participants	1.263	± 0.620

scores of right side at week6

Group	Value	95% CI
All Study Participants	1.850	± 0.572

scores of right side at week8

Group	Value	95% CI
All Study Participants	1.944	± 0.589

Subjective Global Aesthetic Improvement Scale Score Primary · week2, week4, week6 and week8

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.

scores of left side at week2

Group	Value	95% CI
All Study Participants	1.211	± 0.979

scores of left side at week4

Group	Value	95% CI
All Study Participants	1.619	± 0.669

scores of left side at week6

Group	Value	95% CI
All Study Participants	2.050	± 0.589

scores of left side at week8

Group	Value	95% CI
All Study Participants	1.833	± 0.725

scores of right side at week2

Group	Value	95% CI
All Study Participants	1.158	± 0.962

scores of right side at week4

Group	Value	95% CI
All Study Participants	1.667	± 0.796

scores of right side at week6

Group	Value	95% CI
All Study Participants	2.000	± 0.632

scores of right side at week8

Group	Value	95% CI
All Study Participants	1.833	± 0.725

Transepidermal Water Loss (TEWL) Measurement of Lesional Area Primary · week0, week2, week4, week6 and week8

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 an

values of left side at baseline

Group	Value	95% CI
All Study Participants	15.720	± 4.715

values of left side at week2

Group	Value	95% CI
All Study Participants	15.097	± 4.600

values of left side at week4

Group	Value	95% CI
All Study Participants	15.516	± 4.820

values of left side at week6

Group	Value	95% CI
All Study Participants	14.042	± 5.067

values of left side at week8

Group	Value	95% CI
All Study Participants	12.688	± 3.927

values of right side at baseline

Group	Value	95% CI
All Study Participants	14.834	± 3.691

values of right side at week2

Group	Value	95% CI
All Study Participants	15.933	± 3.934

values of right side at week4

Group	Value	95% CI
All Study Participants	16.136	± 4.113

Skin Elasticity Measurement of Lesional Area Primary · week0, week2, week4, week6 and week8

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-value

values of left side at baseline

Group	Value	95% CI
All Study Participants	0.710	± 0.126

values of left side at week2

Group	Value	95% CI
All Study Participants	0.744	± 0.127

values of left side at week4

Group	Value	95% CI
All Study Participants	0.810	± 0.106

values of left side at week6

Group	Value	95% CI
All Study Participants	0.792	± 0.101

values of left side at week8

Group	Value	95% CI
All Study Participants	0.825	± 0.073

values of right side at baseline

Group	Value	95% CI
All Study Participants	0.736	± 0.142

values of right side at week2

Group	Value	95% CI
All Study Participants	0.752	± 0.126

values of right side at week4

Group	Value	95% CI
All Study Participants	0.783	± 0.125

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 weeks, 4 weeks, 6 weeks and 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (2 terms — click to expand)

Reaction	System	Patients
Pain sensation post treatment	Skin and subcutaneous tissue disorders	—
edema	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT06288607 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.