The First Affiliated Hospital with Nanjing Medical University
Phase
Not applicable
Started
2024-10-20
Last updated
2025-11-25
Condition(s) studied
Melasma (Facial Melasma)
Investigational drug(s) / intervention(s)
10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min
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
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
Study 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
Sex
ALL
Min age
20 Years
Max age
55 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
percentage reduction in hemi-MASI — From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention mean percentage reduction in hemi-MASI from baseline to week 20
Trial sites (1)
Facility
City
Region
Status
The first Affiliated hospital with Nanjing medical university
Nanjing
Jiangsu
Recruiting
More The First Affiliated Hospital with Nanjing Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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