Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-20

Study Completion Date

2026-02-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Melasma (Facial Melasma)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Topical treatment with Ultrasound

10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² for 10mins

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Topical treatment without Ultrasound

10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² for 10mins

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No