Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min, 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min.
- Who it may be relevant to
- Registry conditions: Melasma (Facial Melasma). Basic parameters: 20 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma
Overview
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.
Interventions
- Device 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 - Other 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
Primary outcome measures
- percentage reduction in hemi-MASI [Time frame: From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]
Secondary outcome measures (4)
- Patient self-assessment [Time frame: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention]
- Clinical Efficacy [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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The first Affiliated hospital with Nanjing medical university — Nanjing
Identifiers
NCT: NCT07202156 · SR-820