Safety and Efficacy of High Intensity Focused Ultrasound in Solar Lentigo: A Self-controlled Study

This trial is a single-center, prospective self-controlled study. The study proposes to recruit 30 patients with solar lentigo on both sides of the face. Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated. The Lab* values of the lesion area and the area around the lesion are detected separately using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and skin lesion images are collected with dermatoscope and VISIA® (Canfield Company, USA). Measurements of Lab* values 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. At the end of the follow-up on the treatment side, the same parameter treatment is provided for the untreated side, and the corresponding observation items are recorded for the patient before treatment, and at week2, week4, and week6 respectively.

Study Overview

• Status: Active, not recruiting
• Conditions: Solar Lentigo
• Intervention / Treatment: Device: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

The study population for this trial consisted of adult males and females, aged 18 to 60 years, diagnosed with solar lentigo. The participants were recruited from The First Affiliated Hospital with Nanjing Medical University.

Description

Inclusion Criteria:

1. adults between 18 and 60 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 diabetes, malignant tumors, epilepsy, severe liver, kidney, or heart conditions, or any other acute or chronic medical history that could potentially affect the effectiveness or safety outcomes of this trial;
5. those with scar physique;
6. those with inflammatory or infectious skin diseases;
7. 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;
8. those who have undergone high-intensity focused ultrasound treatment within the last six months;
9. Those with serious heart, brain, lung, liver and kidney function damage; Pregnant and lactating women;
10. Those who have a history of psychological and mental illness, recent history of alcoholism or drug abuse;
11. patients who are unwilling to sign the informed consent and who are unwilling to cooperate.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients; Patients with solar lentigo

Device: High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China); Patients are randomly assigned to be treated with high-intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China) on one side, and the other side is not treated.Before treatment, patients are allowed to sign an informed consent form. Before and after treatment, the L*a*b* values of the lesion area and the area around the lesion are detected using 3nh HIGH-QUALITY COLORMETER colorimeter (Konica-Minolta Company, Japan), and photos of the patient's treatment area and dermatoscope observation results are taken. Before treatment, a 2-3mm thick medical condensation gel is evenly applied on the face. During the process, D4.5+D3.0 transducer are used.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lab* values	Lab* values refer to a method of quantifying skin color. 'L*' stands for lightness, 'a*' represents the red/green component, and 'b*' represents the yellow/blue component.	week0, week2, week4 and week6
Physician Global Aesthetic Improvement Scale	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.	week0, week2, week4 and week6
Subjective Global Aesthetic Improvement Scale	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.	week0, week2, week4 and week6

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Investigators: Principal Investigator: Yang Xu, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2023
• Primary Completion (Estimated): April 18, 2024
• Study Completion (Estimated): April 18, 2024

Study Registration Dates

• First Submitted: February 25, 2024
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Actual): March 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo
• Other Study ID Numbers: 2023-SR-708

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No