Loading clinical trials...

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population | Clinical Trials | Clareo Health

COMPLETED

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population: A Prospective Study

NCT06288607•The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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;

Locations (1)

Jiangsu Province Hospital, the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Key Dates

Start Date

November 16, 2023

Primary Completion Date

May 4, 2024

Completion Date

May 4, 2024

Last Updated

June 5, 2025

Enrollment

ACTUAL participants

Conditions

Solar Lentigo

Interventions

High intensity focused ultrasound (MFUS One, Hunan Peninsula Medical Technology Co., Ltd., China)

DEVICE

Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face

NCT06305897

LentigoSolar Lentigo+1 more

View study

UNKNOWNNA

Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins

NCT05886010

Solar LentigoSenile Lentigo

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Efficacy of High-Intensity Macrofocused Ultrasound for Solar Lentigo in Chinese Population

Inclusion Criteria

Exclusion Criteria

Evaluation of the Tolerance (Main Objective) and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-inflammatory Hyperpigmentation) on the Face

Performance and Tolerance of Cyto-selective Difluoroethane-based Cryotherapy in th Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation) on the Face and Hands of Asian Ethnicity Skins

Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots (Solar and Senile Lentigines, Post-Inflammatory Hyperpigmentation)

Clinical Evaluation of the Performance of a Difluoroethane-based Cyto-selective Cryotherapy to Treat Dark Spots on the Hand in 30 Volunteers.