Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma

Not Applicable

Not yet recruiting

• Conditions: Melasma (Facial Melasma)

• Registration Number: NCT07202156
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-20
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-01
• Last Update Posted: 2025-10-01
• Primary Completion: 2026-02-07
• Study Completion: 2026-02-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Patient self-assessment	week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention	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	week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention	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	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	The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention

Trial Locations

Locations (1)

The first Affiliated hospital with Nanjing medical university; 🇨🇳 Nanjing, Jiangsu, China