Clinical trial NCT06288607: Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population
Official title: Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solar Lentigo
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population for this trial consisted of adult males and females, aged 18 to 70 years, diagnosed with solar lentigo. The participants were recruited from The First Affiliated Hospital with Nanjing Medical University.

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Lab* Values of Lesional Area Using Dermoscopy and ImageJ
timeFrame: week0, week2, week4, week6 and week8
measure: Physician Global Aesthetic Improvement Scale Score
timeFrame: week2, week4, week6 and week8
measure: Subjective Global Aesthetic Improvement Scale Score
timeFrame: week2, week4, week6 and week8
measure: Transepidermal Water Loss (TEWL) Measurement of Lesional Area
timeFrame: week0, week2, week4, week6 and week8
measure: Skin Elasticity Measurement of Lesional Area
timeFrame: week0, week2, week4, week6 and week8
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yang Xu
role: PRINCIPAL_INVESTIGATOR
References: