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.
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(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.
Parallel
10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min
Device5w/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
Other interventiontopical 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
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%
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%.
VISIA Digital Skin Analysis
Melasma Quality of Life Scale (MELASQOL) Score
Two-Photon Microscopic Imaging
This was to monitor experimental safety and the impact on the skin barrier.
Dermatoscopy
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