Solar Lentigo
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Lab* Values of Lesional Area Using Dermoscopy and ImageJ | 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 | 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 | 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 | 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 | 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 21 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 47.8 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 type | EG000 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
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of left side at baseline | 68.850 unitless | Standard Deviation 5.952 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of left side at week2 | 72.103 unitless | Standard Deviation 8.324 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of left side at week4 | 73.147 unitless | Standard Deviation 6.483 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of left side at week6 | 72.633 unitless | Standard Deviation 5.007 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of left side at week8 | 73.646 unitless | Standard Deviation 3.532 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of right side at baseline | 68.671 unitless | Standard Deviation 8.038 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of right side at week2 | 71.433 unitless | Standard Deviation 8.643 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of right side at week4 | 72.756 unitless | Standard Deviation 7.085 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of right side at week6 | 72.902 unitless | Standard Deviation 4.843 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | L* of right side at week8 | 72.600 unitless | Standard Deviation 5.285 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of left side at baseline | 13.597 unitless | Standard Deviation 5.582 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of left side at week2 | 11.476 unitless | Standard Deviation 5.69 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of left side at week4 | 9.948 unitless | Standard Deviation 3.42 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of left side at week6 | 9.787 unitless | Standard Deviation 3.633 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of left side at week8 | 9.295 unitless | Standard Deviation 2.826 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of right side at baseline | 13.099 unitless | Standard Deviation 6.385 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of right side at week2 | 11.818 unitless | Standard Deviation 6.368 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of right side at week4 | 10.065 unitless | Standard Deviation 4.108 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of right side at week6 | 9.732 unitless | Standard Deviation 2.83 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | a* of right side at week8 | 9.233 unitless | Standard Deviation 2.969 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of left side at baseline | 18.324 unitless | Standard Deviation 8.494 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of left side at week2 | 12.285 unitless | Standard Deviation 6.681 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of left side at week4 | 12.464 unitless | Standard Deviation 7.88 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of left side at week6 | 10.642 unitless | Standard Deviation 4.954 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of left side at week8 | 11.482 unitless | Standard Deviation 6.779 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of right side at baseline | 17.592 unitless | Standard Deviation 7.356 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of right side at week2 | 14.036 unitless | Standard Deviation 5.686 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of right side at week4 | 12.348 unitless | Standard Deviation 7.172 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of right side at week6 | 11.687 unitless | Standard Deviation 4.498 |
| All Study Participants | Lab* Values of Lesional Area Using Dermoscopy and ImageJ | b* of right side at week8 | 12.737 unitless | Standard Deviation 4.198 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of left side at week2 | 0.800 score on a scale | Standard Deviation 0.51 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of left side at week4 | 1.368 score on a scale | Standard Deviation 0.47 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of left side at week6 | 1.850 score on a scale | Standard Deviation 0.477 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of left side at week8 | 1.889 score on a scale | Standard Deviation 0.624 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of right side at week2 | 0.900 score on a scale | Standard Deviation 0.436 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of right side at week4 | 1.263 score on a scale | Standard Deviation 0.62 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of right side at week6 | 1.850 score on a scale | Standard Deviation 0.572 |
| All Study Participants | Physician Global Aesthetic Improvement Scale Score | scores of right side at week8 | 1.944 score on a scale | Standard Deviation 0.589 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of left side at baseline | 0.710 dimensionless unit | Standard Deviation 0.126 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of left side at week2 | 0.744 dimensionless unit | Standard Deviation 0.127 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of left side at week4 | 0.810 dimensionless unit | Standard Deviation 0.106 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of left side at week6 | 0.792 dimensionless unit | Standard Deviation 0.101 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of left side at week8 | 0.825 dimensionless unit | Standard Deviation 0.073 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of right side at baseline | 0.736 dimensionless unit | Standard Deviation 0.142 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of right side at week2 | 0.752 dimensionless unit | Standard Deviation 0.126 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of right side at week4 | 0.783 dimensionless unit | Standard Deviation 0.125 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of right side at week6 | 0.821 dimensionless unit | Standard Deviation 0.104 |
| All Study Participants | Skin Elasticity Measurement of Lesional Area | values of right side at week8 | 0.807 dimensionless unit | Standard Deviation 0.066 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of left side at week2 | 1.211 score on a scale | Standard Deviation 0.979 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of left side at week4 | 1.619 score on a scale | Standard Deviation 0.669 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of left side at week6 | 2.050 score on a scale | Standard Deviation 0.589 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of left side at week8 | 1.833 score on a scale | Standard Deviation 0.725 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of right side at week2 | 1.158 score on a scale | Standard Deviation 0.962 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of right side at week4 | 1.667 score on a scale | Standard Deviation 0.796 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of right side at week6 | 2.000 score on a scale | Standard Deviation 0.632 |
| All Study Participants | Subjective Global Aesthetic Improvement Scale Score | scores of right side at week8 | 1.833 score on a scale | Standard Deviation 0.725 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of right side at baseline | 14.834 g/m²/h | Standard Deviation 3.691 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of right side at week2 | 15.933 g/m²/h | Standard Deviation 3.934 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of right side at week4 | 16.136 g/m²/h | Standard Deviation 4.113 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of right side at week6 | 14.891 g/m²/h | Standard Deviation 3.848 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of right side at week8 | 13.478 g/m²/h | Standard Deviation 3.624 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of left side at baseline | 15.720 g/m²/h | Standard Deviation 4.715 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of left side at week2 | 15.097 g/m²/h | Standard Deviation 4.6 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of left side at week4 | 15.516 g/m²/h | Standard Deviation 4.82 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of left side at week6 | 14.042 g/m²/h | Standard Deviation 5.067 |
| All Study Participants | Transepidermal Water Loss (TEWL) Measurement of Lesional Area | values of left side at week8 | 12.688 g/m²/h | Standard Deviation 3.927 |