An observational study in Solar Lentigo, sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-06-05.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
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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.
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Exclusion Criteria:
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with solar lentigo
Device: 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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week0, week2, week4, week6 and week8
| Milestone | All Study Participants |
|---|---|
| Started | 21 |
| Completed | 21 |
| Not completed | 0 |
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.
| unitless | All Study Participants |
|---|---|
| L* of left side at baseline | 68.850 ± 5.952 |
| L* of left side at week2 | 72.103 ± 8.324 |
| L* of left side at week4 | 73.147 ± 6.483 |
| L* of left side at week6 | 72.633 ± 5.007 |
| L* of left side at week8 | 73.646 ± 3.532 |
| L* of right side at baseline | 68.671 ± 8.038 |
| L* of right side at week2 | 71.433 ± 8.643 |
| L* of right side at week4 | 72.756 ± 7.085 |
| L* of right side at week6 | 72.902 ± 4.843 |
| L* of right side at week8 | 72.600 ± 5.285 |
| a* of left side at baseline | 13.597 ± 5.582 |
| a* of left side at week2 | 11.476 ± 5.690 |
| a* of left side at week4 | 9.948 ± 3.420 |
| a* of left side at week6 | 9.787 ± 3.633 |
| a* of left side at week8 | 9.295 ± 2.826 |
| a* of right side at baseline | 13.099 ± 6.385 |
| a* of right side at week2 | 11.818 ± 6.368 |
| a* of right side at week4 | 10.065 ± 4.108 |
| a* of right side at week6 | 9.732 ± 2.830 |
| a* of right side at week8 | 9.233 ± 2.969 |
| b* of left side at baseline | 18.324 ± 8.494 |
| b* of left side at week2 | 12.285 ± 6.681 |
| b* of left side at week4 | 12.464 ± 7.880 |
| b* of left side at week6 | 10.642 ± 4.954 |
| b* of left side at week8 | 11.482 ± 6.779 |
| b* of right side at baseline | 17.592 ± 7.356 |
| b* of right side at week2 | 14.036 ± 5.686 |
| b* of right side at week4 | 12.348 ± 7.172 |
| b* of right side at week6 | 11.687 ± 4.498 |
| b* of right side at week8 | 12.737 ± 4.198 |
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.
| score on a scale | All Study Participants |
|---|---|
| scores of left side at week2 | 0.800 ± 0.510 |
| scores of left side at week4 | 1.368 ± 0.470 |
| scores of left side at week6 | 1.850 ± 0.477 |
| scores of left side at week8 | 1.889 ± 0.624 |
| scores of right side at week2 | 0.900 ± 0.436 |
| scores of right side at week4 | 1.263 ± 0.620 |
| scores of right side at week6 | 1.850 ± 0.572 |
| scores of right side at week8 | 1.944 ± 0.589 |
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.
| score on a scale | All Study Participants |
|---|---|
| scores of left side at week2 | 1.211 ± 0.979 |
| scores of left side at week4 | 1.619 ± 0.669 |
| scores of left side at week6 | 2.050 ± 0.589 |
| scores of left side at week8 | 1.833 ± 0.725 |
| scores of right side at week2 | 1.158 ± 0.962 |
| scores of right side at week4 | 1.667 ± 0.796 |
| scores of right side at week6 | 2.000 ± 0.632 |
| scores of right side at week8 | 1.833 ± 0.725 |
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.
| g/m²/h | All Study Participants |
|---|---|
| values of left side at baseline | 15.720 ± 4.715 |
| values of left side at week2 | 15.097 ± 4.600 |
| values of left side at week4 | 15.516 ± 4.820 |
| values of left side at week6 | 14.042 ± 5.067 |
| values of left side at week8 | 12.688 ± 3.927 |
| values of right side at baseline | 14.834 ± 3.691 |
| values of right side at week2 | 15.933 ± 3.934 |
| values of right side at week4 | 16.136 ± 4.113 |
| values of right side at week6 | 14.891 ± 3.848 |
| values of right side at week8 | 13.478 ± 3.624 |
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.
| dimensionless unit | All Study Participants |
|---|---|
| values of left side at baseline | 0.710 ± 0.126 |
| values of left side at week2 | 0.744 ± 0.127 |
| values of left side at week4 | 0.810 ± 0.106 |
| values of left side at week6 | 0.792 ± 0.101 |
| values of left side at week8 | 0.825 ± 0.073 |
| values of right side at baseline | 0.736 ± 0.142 |
| values of right side at week2 | 0.752 ± 0.126 |
| values of right side at week4 | 0.783 ± 0.125 |
| values of right side at week6 | 0.821 ± 0.104 |
| values of right side at week8 | 0.807 ± 0.066 |
Collected over 2 weeks, 4 weeks, 6 weeks and 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients | 0/21 (0%) | 0/21 (0%) | 2/21 (9.5%) |
| Event | Patients |
|---|---|
| Pain sensation post treatmentSkin and subcutaneous tissue disorders | 2/21 |
| edemaSkin and subcutaneous tissue disorders | 2/21 |
The baseline population for this clinical trial consists of all enrolled participants. Baseline data were collected at the individual participant level and include the following characteristics: age, sex, race, Fitzpatrick Skin Type. These baseline data were collected for the entire participant group and represent the overall participant characteristics. The baseline data have been presented at the participant level.
| Age, Continuous(years) | All Study Participants |
|---|---|
| Mean | 47.8 ± 8.9 |
| Sex: Female, Male(Participants) | All Study Participants |
|---|---|
| Female | 20 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | All Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 21 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | All Study Participants |
|---|---|
| China | 21 |
| Fitzpatrick skin type(Participants) | All Study Participants |
|---|---|
| Type I | 0 |
| Type II | 0 |
| Type Ⅲ | 15 |
| Type Ⅳ | 6 |
| Type V | 0 |
| Type VI | 0 |
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital with Nanjing Medical University →