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

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population: A Prospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06288607
Enrollment
21
Registered
2024-03-01
Start date
2023-11-16
Completion date
2024-05-04
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solar Lentigo

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.

Interventions

DEVICEHigh 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.

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years

Inclusion criteria

1. adults between 18 and 70 years old, regardless of gender; 2. comply the clinical diagnostic criteria for solar lentigo on both sides of the face; 3. patients understand and are willing to participate in this clinical trial and voluntarily sign an informed consent form;

Exclusion criteria

1. Women who are pregnant or breastfeeding, or who plan to become pregnant during the trial period; 2. those who are allergic to medical condensation gel; 3. those with photosensitive diseases, immune deficiencies, or those who are taking immunosuppressants; 4. those with scar physique; 5. those with inflammatory or infectious skin diseases; 6. 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; 7. those who have undergone high-intensity focused ultrasound treatment within the last six months;

Design outcomes

Primary

MeasureTime frameDescription
Lab* Values of Lesional Area Using Dermoscopy and ImageJweek0, week2, week4, week6 and week8Before 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 Scoreweek2, week4, week6 and week8Two 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 Scoreweek2, week4, week6 and week8At 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 Areaweek0, week2, week4, week6 and week8Before 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 Areaweek0, week2, week4, week6 and week8Before 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.

Countries

China

Participant flow

Participants by arm

ArmCount
All Study Participants
All participants were to receive high intensity macro-focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). No grouping was performed, both sides of the face received treatment with identical parameters. 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. Outcomes were compared with data before and after treatment.
21
Total21

Baseline characteristics

CharacteristicAll Study Participants
Age, Continuous47.8 years
STANDARD_DEVIATION 8.9
Fitzpatrick skin type
Type Ⅲ
15 Participants
Fitzpatrick skin type
Type Ⅳ
6 Participants
Fitzpatrick skin type
Type I
0 Participants
Fitzpatrick skin type
Type II
0 Participants
Fitzpatrick skin type
Type V
0 Participants
Fitzpatrick skin type
Type VI
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
21 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
0 Participants
Region of Enrollment
China
21 participants
Sex: Female, Male
Female
20 Participants
Sex: Female, Male
Male
1 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 21
other
Total, other adverse events
2 / 21
serious
Total, serious adverse events
0 / 21

Outcome results

Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of left side at baseline68.850 unitlessStandard Deviation 5.952
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of left side at week272.103 unitlessStandard Deviation 8.324
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of left side at week473.147 unitlessStandard Deviation 6.483
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of left side at week672.633 unitlessStandard Deviation 5.007
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of left side at week873.646 unitlessStandard Deviation 3.532
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of right side at baseline68.671 unitlessStandard Deviation 8.038
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of right side at week271.433 unitlessStandard Deviation 8.643
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of right side at week472.756 unitlessStandard Deviation 7.085
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of right side at week672.902 unitlessStandard Deviation 4.843
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJL* of right side at week872.600 unitlessStandard Deviation 5.285
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of left side at baseline13.597 unitlessStandard Deviation 5.582
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of left side at week211.476 unitlessStandard Deviation 5.69
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of left side at week49.948 unitlessStandard Deviation 3.42
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of left side at week69.787 unitlessStandard Deviation 3.633
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of left side at week89.295 unitlessStandard Deviation 2.826
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of right side at baseline13.099 unitlessStandard Deviation 6.385
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of right side at week211.818 unitlessStandard Deviation 6.368
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of right side at week410.065 unitlessStandard Deviation 4.108
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of right side at week69.732 unitlessStandard Deviation 2.83
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJa* of right side at week89.233 unitlessStandard Deviation 2.969
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of left side at baseline18.324 unitlessStandard Deviation 8.494
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of left side at week212.285 unitlessStandard Deviation 6.681
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of left side at week412.464 unitlessStandard Deviation 7.88
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of left side at week610.642 unitlessStandard Deviation 4.954
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of left side at week811.482 unitlessStandard Deviation 6.779
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of right side at baseline17.592 unitlessStandard Deviation 7.356
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of right side at week214.036 unitlessStandard Deviation 5.686
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of right side at week412.348 unitlessStandard Deviation 7.172
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of right side at week611.687 unitlessStandard Deviation 4.498
All Study ParticipantsLab* Values of Lesional Area Using Dermoscopy and ImageJb* of right side at week812.737 unitlessStandard Deviation 4.198
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of left side at week20.800 score on a scaleStandard Deviation 0.51
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of left side at week41.368 score on a scaleStandard Deviation 0.47
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of left side at week61.850 score on a scaleStandard Deviation 0.477
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of left side at week81.889 score on a scaleStandard Deviation 0.624
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of right side at week20.900 score on a scaleStandard Deviation 0.436
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of right side at week41.263 score on a scaleStandard Deviation 0.62
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of right side at week61.850 score on a scaleStandard Deviation 0.572
All Study ParticipantsPhysician Global Aesthetic Improvement Scale Scorescores of right side at week81.944 score on a scaleStandard Deviation 0.589
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of left side at baseline0.710 dimensionless unitStandard Deviation 0.126
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of left side at week20.744 dimensionless unitStandard Deviation 0.127
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of left side at week40.810 dimensionless unitStandard Deviation 0.106
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of left side at week60.792 dimensionless unitStandard Deviation 0.101
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of left side at week80.825 dimensionless unitStandard Deviation 0.073
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of right side at baseline0.736 dimensionless unitStandard Deviation 0.142
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of right side at week20.752 dimensionless unitStandard Deviation 0.126
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of right side at week40.783 dimensionless unitStandard Deviation 0.125
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of right side at week60.821 dimensionless unitStandard Deviation 0.104
All Study ParticipantsSkin Elasticity Measurement of Lesional Areavalues of right side at week80.807 dimensionless unitStandard Deviation 0.066
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of left side at week21.211 score on a scaleStandard Deviation 0.979
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of left side at week41.619 score on a scaleStandard Deviation 0.669
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of left side at week62.050 score on a scaleStandard Deviation 0.589
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of left side at week81.833 score on a scaleStandard Deviation 0.725
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of right side at week21.158 score on a scaleStandard Deviation 0.962
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of right side at week41.667 score on a scaleStandard Deviation 0.796
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of right side at week62.000 score on a scaleStandard Deviation 0.632
All Study ParticipantsSubjective Global Aesthetic Improvement Scale Scorescores of right side at week81.833 score on a scaleStandard Deviation 0.725
Primary

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

ArmMeasureGroupValue (MEAN)Dispersion
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of right side at baseline14.834 g/m²/hStandard Deviation 3.691
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of right side at week215.933 g/m²/hStandard Deviation 3.934
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of right side at week416.136 g/m²/hStandard Deviation 4.113
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of right side at week614.891 g/m²/hStandard Deviation 3.848
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of right side at week813.478 g/m²/hStandard Deviation 3.624
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of left side at baseline15.720 g/m²/hStandard Deviation 4.715
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of left side at week215.097 g/m²/hStandard Deviation 4.6
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of left side at week415.516 g/m²/hStandard Deviation 4.82
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of left side at week614.042 g/m²/hStandard Deviation 5.067
All Study ParticipantsTransepidermal Water Loss (TEWL) Measurement of Lesional Areavalues of left side at week812.688 g/m²/hStandard Deviation 3.927

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026