Solar LentigoNCT06288607
Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population
An observational study of Solar Lentigo, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solar Lentigo
- What is being tested?
- High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)
- Type of treatment
- Medical device
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 16 Nov 2023to 4 May 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population: A Prospective Study
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
- Being tested
- High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with solar lentigo Receives: Device: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week0, week2, week4, week6 and week8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start16 Nov 2023
- Primary completion4 May 2024
- Study completion4 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solar LentigoStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Xu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288607
- Sponsor's protocol ID
- 2023-SR-708
- Status last verified
- May 2025
- First submitted
- 25 Feb 2024
- Last updated
- 5 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population: A Prospective Study
- ClinicalTrials.gov ID
- NCT06288607
- Acronym / sponsor ID
- 2023-SR-708
- Conditions
- Solar Lentigo
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 4 May 2024 (actual)
- Study completion
- 4 May 2024 (actual)
- First posted
- 1 Mar 2024 (actual)
- Results
- Posted 5 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)Patients with solar lentigo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients |
Primary outcome
Lab* Values of Lesional Area Using Dermoscopy and ImageJ
Time frame: 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 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.
Physician Global Aesthetic Improvement Scale Score
Time frame: 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.
Subjective Global Aesthetic Improvement Scale Score
Time frame: 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.
Transepidermal Water Loss (TEWL) Measurement of Lesional Area
Time frame: 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 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.
Skin Elasticity Measurement of Lesional Area
Time frame: 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-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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Xu principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solar Lentigo, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lab* Values of Lesional Area Using Dermoscopy and ImageJ (time frame: week0, week2, week4, week6 and week8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.