Trial Outcomes & Findings for Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population (NCT NCT06288607)
NCT ID: NCT06288607
Last Updated: 2025-06-05
Results Overview
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.
COMPLETED
21 participants
week0, week2, week4, week6 and week8
2025-06-05
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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21
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Overall Study
COMPLETED
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21
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population
Baseline characteristics by cohort
| Measure |
All Study Participants
n=21 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.
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|---|---|
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Age, Continuous
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47.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
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Sex: Female, Male
Female
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20 Participants
n=5 Participants
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Sex: Female, Male
Male
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1 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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21 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
China
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21 participants
n=5 Participants
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Fitzpatrick skin type
Type I
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0 Participants
n=5 Participants
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Fitzpatrick skin type
Type II
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0 Participants
n=5 Participants
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Fitzpatrick skin type
Type Ⅲ
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15 Participants
n=5 Participants
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Fitzpatrick skin type
Type Ⅳ
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6 Participants
n=5 Participants
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Fitzpatrick skin type
Type V
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0 Participants
n=5 Participants
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Fitzpatrick skin type
Type VI
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: week0, 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.
Outcome measures
| Measure |
All Study Participants
n=21 Participants
All participants were to receive high intensity macro-focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). 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. Each area was treated first at 3.0mm then at 4.5mm depth. Since the individual effects of each depth could not be determined during follow-up, the results reflect the combined effects of both depths.
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of right side at baseline
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13.099 unitless
Standard Deviation 6.385
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of right side at week2
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11.818 unitless
Standard Deviation 6.368
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of left side at week2
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11.476 unitless
Standard Deviation 5.690
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of left side at week4
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9.948 unitless
Standard Deviation 3.420
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of left side at week6
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9.787 unitless
Standard Deviation 3.633
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of left side at week8
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9.295 unitless
Standard Deviation 2.826
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of right side at week4
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10.065 unitless
Standard Deviation 4.108
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of right side at week6
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9.732 unitless
Standard Deviation 2.830
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of right side at week8
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9.233 unitless
Standard Deviation 2.969
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of left side at baseline
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18.324 unitless
Standard Deviation 8.494
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of left side at week2
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12.285 unitless
Standard Deviation 6.681
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of left side at week4
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12.464 unitless
Standard Deviation 7.880
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of left side at week6
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10.642 unitless
Standard Deviation 4.954
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of left side at week8
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11.482 unitless
Standard Deviation 6.779
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of right side at baseline
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17.592 unitless
Standard Deviation 7.356
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of right side at week2
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14.036 unitless
Standard Deviation 5.686
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of right side at week4
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12.348 unitless
Standard Deviation 7.172
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of right side at week6
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11.687 unitless
Standard Deviation 4.498
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
b* of right side at week8
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12.737 unitless
Standard Deviation 4.198
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of left side at baseline
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68.850 unitless
Standard Deviation 5.952
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of left side at week2
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72.103 unitless
Standard Deviation 8.324
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of left side at week4
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73.147 unitless
Standard Deviation 6.483
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of left side at week6
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72.633 unitless
Standard Deviation 5.007
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of left side at week8
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73.646 unitless
Standard Deviation 3.532
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of right side at baseline
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68.671 unitless
Standard Deviation 8.038
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of right side at week2
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71.433 unitless
Standard Deviation 8.643
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of right side at week4
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72.756 unitless
Standard Deviation 7.085
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of right side at week6
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72.902 unitless
Standard Deviation 4.843
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
L* of right side at week8
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72.600 unitless
Standard Deviation 5.285
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Lab* Values of Lesional Area Using Dermoscopy and ImageJ
a* of left side at baseline
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13.597 unitless
Standard Deviation 5.582
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PRIMARY outcome
Timeframe: week2, 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.
Outcome measures
| Measure |
All Study Participants
n=21 Participants
All participants were to receive high intensity macro-focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). 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. Each area was treated first at 3.0mm then at 4.5mm depth. Since the individual effects of each depth could not be determined during follow-up, the results reflect the combined effects of both depths.
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|---|---|
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Physician Global Aesthetic Improvement Scale Score
scores of left side at week2
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0.800 score on a scale
Standard Deviation 0.510
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Physician Global Aesthetic Improvement Scale Score
scores of left side at week4
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1.368 score on a scale
Standard Deviation 0.470
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Physician Global Aesthetic Improvement Scale Score
scores of left side at week6
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1.850 score on a scale
Standard Deviation 0.477
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Physician Global Aesthetic Improvement Scale Score
scores of left side at week8
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1.889 score on a scale
Standard Deviation 0.624
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Physician Global Aesthetic Improvement Scale Score
scores of right side at week2
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0.900 score on a scale
Standard Deviation 0.436
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Physician Global Aesthetic Improvement Scale Score
scores of right side at week4
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1.263 score on a scale
Standard Deviation 0.620
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Physician Global Aesthetic Improvement Scale Score
scores of right side at week6
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1.850 score on a scale
Standard Deviation 0.572
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Physician Global Aesthetic Improvement Scale Score
scores of right side at week8
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1.944 score on a scale
Standard Deviation 0.589
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PRIMARY outcome
Timeframe: week2, 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.
Outcome measures
| Measure |
All Study Participants
n=21 Participants
All participants were to receive high intensity macro-focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). 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. Each area was treated first at 3.0mm then at 4.5mm depth. Since the individual effects of each depth could not be determined during follow-up, the results reflect the combined effects of both depths.
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|---|---|
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Subjective Global Aesthetic Improvement Scale Score
scores of left side at week2
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1.211 score on a scale
Standard Deviation 0.979
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Subjective Global Aesthetic Improvement Scale Score
scores of left side at week4
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1.619 score on a scale
Standard Deviation 0.669
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Subjective Global Aesthetic Improvement Scale Score
scores of left side at week6
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2.050 score on a scale
Standard Deviation 0.589
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Subjective Global Aesthetic Improvement Scale Score
scores of left side at week8
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1.833 score on a scale
Standard Deviation 0.725
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Subjective Global Aesthetic Improvement Scale Score
scores of right side at week2
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1.158 score on a scale
Standard Deviation 0.962
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Subjective Global Aesthetic Improvement Scale Score
scores of right side at week4
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1.667 score on a scale
Standard Deviation 0.796
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Subjective Global Aesthetic Improvement Scale Score
scores of right side at week6
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2.000 score on a scale
Standard Deviation 0.632
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Subjective Global Aesthetic Improvement Scale Score
scores of right side at week8
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1.833 score on a scale
Standard Deviation 0.725
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PRIMARY outcome
Timeframe: week0, 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.
Outcome measures
| Measure |
All Study Participants
n=21 Participants
All participants were to receive high intensity macro-focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). 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. Each area was treated first at 3.0mm then at 4.5mm depth. Since the individual effects of each depth could not be determined during follow-up, the results reflect the combined effects of both depths.
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|---|---|
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of left side at baseline
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15.720 g/m²/h
Standard Deviation 4.715
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of left side at week2
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15.097 g/m²/h
Standard Deviation 4.600
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of left side at week4
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15.516 g/m²/h
Standard Deviation 4.820
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of left side at week6
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14.042 g/m²/h
Standard Deviation 5.067
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of left side at week8
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12.688 g/m²/h
Standard Deviation 3.927
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of right side at baseline
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14.834 g/m²/h
Standard Deviation 3.691
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of right side at week2
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15.933 g/m²/h
Standard Deviation 3.934
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of right side at week4
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16.136 g/m²/h
Standard Deviation 4.113
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of right side at week6
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14.891 g/m²/h
Standard Deviation 3.848
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Transepidermal Water Loss (TEWL) Measurement of Lesional Area
values of right side at week8
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13.478 g/m²/h
Standard Deviation 3.624
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PRIMARY outcome
Timeframe: week0, 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.
Outcome measures
| Measure |
All Study Participants
n=21 Participants
All participants were to receive high intensity macro-focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China). 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. Each area was treated first at 3.0mm then at 4.5mm depth. Since the individual effects of each depth could not be determined during follow-up, the results reflect the combined effects of both depths.
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|---|---|
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Skin Elasticity Measurement of Lesional Area
values of left side at baseline
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0.710 dimensionless unit
Standard Deviation 0.126
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Skin Elasticity Measurement of Lesional Area
values of left side at week2
|
0.744 dimensionless unit
Standard Deviation 0.127
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Skin Elasticity Measurement of Lesional Area
values of left side at week4
|
0.810 dimensionless unit
Standard Deviation 0.106
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Skin Elasticity Measurement of Lesional Area
values of left side at week6
|
0.792 dimensionless unit
Standard Deviation 0.101
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Skin Elasticity Measurement of Lesional Area
values of left side at week8
|
0.825 dimensionless unit
Standard Deviation 0.073
|
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Skin Elasticity Measurement of Lesional Area
values of right side at baseline
|
0.736 dimensionless unit
Standard Deviation 0.142
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Skin Elasticity Measurement of Lesional Area
values of right side at week2
|
0.752 dimensionless unit
Standard Deviation 0.126
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Skin Elasticity Measurement of Lesional Area
values of right side at week4
|
0.783 dimensionless unit
Standard Deviation 0.125
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Skin Elasticity Measurement of Lesional Area
values of right side at week6
|
0.821 dimensionless unit
Standard Deviation 0.104
|
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Skin Elasticity Measurement of Lesional Area
values of right side at week8
|
0.807 dimensionless unit
Standard Deviation 0.066
|
Adverse Events
Patients
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients
n=21 participants at risk
Patients with solar lentigo
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pain sensation post treatment
|
9.5%
2/21 • 2 weeks, 4 weeks, 6 weeks and 8 weeks
Patients were treated with two macro-focused handpieces with focal depths at 3.0 mm (D3.0) and 4.5 mm (D4.5) on both side. Given that each patient was subjected to treatment with both 3.0mm and 4.5mm handpieces, it was not possible to distinguish adverse events related to different depths during follow-up. Therefore, these events were synthesized into an overall assessment of adverse events.
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|
Skin and subcutaneous tissue disorders
edema
|
9.5%
2/21 • 2 weeks, 4 weeks, 6 weeks and 8 weeks
Patients were treated with two macro-focused handpieces with focal depths at 3.0 mm (D3.0) and 4.5 mm (D4.5) on both side. Given that each patient was subjected to treatment with both 3.0mm and 4.5mm handpieces, it was not possible to distinguish adverse events related to different depths during follow-up. Therefore, these events were synthesized into an overall assessment of adverse events.
|
Additional Information
Dr. Yang Xu
The First Affiliated Hospital with Nanjing Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place