Actively Recruiting
Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2025-11-25
35
Participants Needed
1
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 20 to 55 years (inclusive)
- Clinically diagnosed with melasma and confirmed by the investigator
- Willing to comply with follow-up visits and provide facial photos
- Understand and agree to participate by signing informed consent
You will not qualify if you...
- Females who are pregnant, breastfeeding, or planning pregnancy during the trial
- Known allergy to tranexamic acid or any excipient in the product
- History of thrombosis or thrombotic conditions or unable to stop certain medications
- History of visual or eye abnormalities caused by retinal blood vessel issues
- Use of topical steroids for skin inflammation for over one month
- Skin abnormalities at treatment site like moles, ulcers, or erosions
- Any acute or chronic medical condition affecting safety or trial validity
- Abnormal lab test results before the trial
- Participation in another clinical trial within 30 days before screening
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The first Affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, China, 210009
Actively Recruiting
Research Team
L
Lu Yan, phD
CONTACT
L
Lu Yan, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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