RecruitingNot ApplicableNCT07202156

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

35 participants

Start Date

Oct 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 20 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min and a medical device called 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min for people with melasma (facial melasma). The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICE10%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

OTHER10%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

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NCT07202156


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