Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma

NCT07202156 | Recruiting DMC

• 1 other identifier: SR-820
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Melasma (Facial Melasma)

Outcome Measures

Primary Outcomes (1)

• percentage reduction in hemi-MASI

  mean percentage reduction in hemi-MASI from baseline to week 20

  From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention

Secondary Outcomes (4)

• Patient self-assessment

  week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention

• Clinical Efficacy

  week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention

• 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

Other Outcomes (2)

• Two-Photon Microscopic Imaging

  The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention

• Dermatoscopy

  The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention

Study Arms (2)

Topical treatment with Ultrasound

EXPERIMENTAL

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

Topical treatment without Ultrasound

OTHER

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

Interventions

10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min DEVICE

5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins

Topical treatment with Ultrasound

10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min OTHER

topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins

Topical treatment without Ultrasound

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The first Affiliated hospital with Nanjing medical university

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Melanosis

Condition Hierarchy (Ancestors)

Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lu Yan

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Lu Yan, phD

CONTACT

13913967126; luyan6289@163.com

Lu Yan, phD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 1, 2025
• Study Start: October 20, 2024
• Primary Completion: February 7, 2026
• Study Completion: February 25, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)