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RECRUITING
NCT07202156
NA

Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma

Sponsor: The First Affiliated Hospital with Nanjing Medical University

View on ClinicalTrials.gov

Summary

Melasma is a localized, acquired hyperpigmentary skin disorder characterized by well-defined, light to dark brown patches. Based on clinical practice and extensive literature reports, tranexamic acid and reduced Glutathione (GSH) are both applied in the treatment of melasma, but their water-soluble nature presents challenges for transdermal absorption. Our preliminary basic and clinical research has demonstrated that ultrasound-assisted delivery significantly enhances the absorption of tranexamic acid and other water-soluble components. Its effect on the skin barrier is temporary and reversible. This study aims to evaluate the efficacy and safety of a compound solution (10% tranexamic acid, 2% GSH) delivered via ultrasound for melasma treatment through a split-face controlled trial.

Official title: Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma

Key Details

Gender

All

Age Range

20 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-10-20

Completion Date

2026-02-25

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DEVICE

10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min

5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins

OTHER

10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min

topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins

Locations (1)

The first Affiliated hospital with Nanjing medical university

Nanjing, Jiangsu, China