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

Solar Lentigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06288607
• Other study ID #: 2023-SR-708
• Status: Active, not recruiting
• Start date: November 16, 2023
• Est. completion date: April 18, 2024

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 18, 2024
• Est. primary completion date: April 18, 2024
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigo

Intervention

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.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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