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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
35
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
The first Affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, China
RECRUITINGpercentage 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
Lu Yan, phD
CONTACT
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