Ultrasound-enhanced delivery of tranexamic acid and glutathione for facial melasma
Official title: Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07202156 · Data updated 2026-11-12
This trial will test whether using ultrasound to help the skin absorb a 10% tranexamic acid and 2% glutathione solution reduces facial melasma in adults aged 20–55.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 55 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | October 20, 2024 |
| Main results expected | February 7, 2026 |
| Study ends | February 25, 2026 |
| Registry record updated | November 25, 2025 |
| Trial ID | NCT07202156 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 20–55 with clinically diagnosed facial melasma who can consent, comply with follow-up visits, and agree to photographic documentation are ideal candidates.
✕Probably not a fit
People who are pregnant or breastfeeding, allergic to tranexamic acid, have a history of thrombosis or certain ocular problems, or cannot stop estrogen-containing medications are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized split-face controlled trial compares a compound solution (10% tranexamic acid, 2% reduced glutathione) delivered with active ultrasound (5 W/cm² for 10 minutes) on one side of the face versus the same solution with ultrasound off (0 W/cm²) on the other side. Participants are adults 20–55 with clinically diagnosed facial melasma who will receive topical application, photographic documentation, and scheduled follow-up visits. The approach is based on preliminary basic and clinical data showing ultrasound-assisted delivery improves absorption of water-soluble agents and that the skin-barrier effects are temporary and reversible. Safety monitoring includes screening for allergy to tranexamic acid, thrombotic history, pregnancy/lactation, and ocular abnormalities.
Why it matters
Potential benefit: If successful, this could provide a noninvasive method to improve delivery of water-soluble agents and reduce pigmentation in facial melasma.
How similar studies have gone: Topical and oral tranexamic acid have prior clinical use for melasma and preliminary studies suggest ultrasound can improve transdermal uptake, but larger controlled split-face trials are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: -(1) Male or female participants aged 20 to 55 years (inclusive); (2) Subjects clinically diagnosed with melasma and confirmed by the investigator to meet the trial requirements; (3) Subjects willing to comply with follow-up observations and able to provide portrait rights for documentation purposes; (4) Understanding and willingness to participate in the clinical trial, and voluntarily signing a written informed consent form. Exclusion Criteria: * (1) Females who are pregnant, lactating, or planning to become pregnant during the trial period; (2) Subjects with known allergen to tranexamic acid or any excipient in the investigational product; (3) History of thrombosis or other thrombotic tendencies (e.g., hypertension, hyperlipidemia), or inability to discontinue oral contraceptives, estrogen, or prothrombin complex concentrates during the trial; (4) History of visual or ocular abnormalities (e.g. impaired vision, visual field defects, or fundus hemorrhage/edema) caused by abnormal retinal intravascular coagulation; (5) Patients with skin inflammation who have used topical steroid preparations for more than one month; (6) Presence of skin abnormalities at the trial site, such as nevi, ulcers, or erosions; (7) Any acute or chronic medical history (past or present) that may interfere with the validity or safety assessment of the trial; (8) Clinically significant abnormal laboratory test results prior to the trial; (9) Participation in any other clinical trial within 30 days prior to screening; (10) Any other condition deemed by the investigator to be unsuitable for participation in the study.
Where it's running
-
The first Affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: Lu Yan, phD
- Email: luyan6289@163.com
- Phone: 13913967126
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Cosmetic gel for facial hyperpigmentation in women
This study tests a depigmenting gel to see if it improves facial dark spots in 40 women aged 30–60 over 90 days.
-
Cosmetic serum versus 4% hydroquinone for treating facial melasma over 84 days
This trial tests whether a cosmetic depigmenting serum lightens mild-to-moderate facial melasma and is gentler on the skin than a 4% hydroquinone cream in adults 18–65.
-
Injectable platelet-rich fibrin versus intradermal tranexamic acid for facial melasma
This compares injections of a patient's own platelet-rich fibrin with tiny intradermal tranexamic acid shots to see which reduces facial melasma better in adult women.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.