Status:
RECRUITING
Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Conditions:
Melasma (Facial Melasma)
Eligibility:
All Genders
20-55 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- (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
- (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.
Key Trial Info
Start Date :
October 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT07202156
Start Date
October 20 2024
End Date
February 25 2026
Last Update
November 25 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The first Affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, China, 210009