N/A
N=21
Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population
Solar Lentigo
Bottom Line
View on ClinicalTrials.gov: NCT06288607 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Lab* Values of Lesional Area Using Dermoscopy and ImageJ — 68.850; 72.103; 73.147; 72.633 unitless
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lab* Values of Lesional Area Using Dermoscopy and ImageJ |
68.850; 72.103; 73.147; 72.633; 73.646; 68.671 | — |
| PRIMARY Physician Global Aesthetic Improvement Scale Score |
0.800; 1.368; 1.850; 1.889; 0.900; 1.263 | — |
| PRIMARY Subjective Global Aesthetic Improvement Scale Score |
1.211; 1.619; 2.050; 1.833; 1.158; 1.667 | — |
| PRIMARY Transepidermal Water Loss (TEWL) Measurement of Lesional Area |
15.720; 15.097; 15.516; 14.042; 12.688; 14.834 | — |
| PRIMARY Skin Elasticity Measurement of Lesional Area |
0.710; 0.744; 0.810; 0.792; 0.825; 0.736 | — |
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.
Eligibility Criteria
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;
- 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;
Data sourced from ClinicalTrials.gov (NCT06288607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.