An interventional study of 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min and 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min in Melasma (Facial Melasma), sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Not applicable, Interventional, and Treatment
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.
149 studies on the registry are indexed under Melanosis; 38 are open to participants now.
This study's planned enrollment of 35 is below the median of 40 across 139 interventional studies indexed under Melanosis.
Browse Melanosis studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
Counted across the registry records on this site, refreshed daily.
-(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:
10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² for 10mins
Device: 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min
10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² for 10mins
Other: 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min
5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins
topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins
percentage reduction in hemi-MASI
mean percentage reduction in hemi-MASI from baseline to week 20
Time frame: From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Patient self-assessment
The outcomes were categorized as follows: cured (improvement ≥75%), markedly effective (improvement 50%-75%), effective (improvement 25%-50%), and ineffective (improvement ≤25%). The satisfaction rate was calculated as: Satisfaction rate = (number of cured + markedly effective + effective cases) / total number of cases × 100%
Time frame: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Clinical Efficacy
investigators evaluated the melasma or hyperpigmentation on split-face using the following criteria: Cured: \>90% reduction in pigmented area with virtually disappearance of color upon visual inspection. Markedly Effective: \>60% reduction in area with significant lightening of color. Effective: \>30% reduction in area with noticeable lightening of color. Ineffective: \<30% reduction in area with no significant change in color. The effective rate was calculated as: Effective rate = (number of cured + markedly effective + effective cases) / total number of cases × 100%.
Time frame: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
VISIA Digital Skin Analysis
Time frame: From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Melasma Quality of Life Scale (MELASQOL) Score
Time frame: The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Two-Photon Microscopic Imaging
This was to monitor experimental safety and the impact on the skin barrier.
Time frame: The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Dermatoscopy
Time frame: The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University