NCT07202156

Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melasma (Facial Melasma)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-10-20
• Primary completion: 2026-02-07
• Completion: 2026-02-25
• First posted: 2025-10-01
• Last updated: 2025-11-25

Locations

1 site across 1 country: China