Melasma (Facial Melasma)NCT07202156
Ultrasound-Enhanced Delivery of Compound TXA Solution in Melasma
A study testing 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min and 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min in people with Melasma (Facial Melasma), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Melasma (Facial Melasma)
- What is being tested?
- 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min and 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2024to 25 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -(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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lu Yan, phD contact
China1 site, 1 recruiting
- Recruiting
The first Affiliated hospital with Nanjing medical university
Nanjing, Jiangsu, 210009
Pan Yueyun, 15851837753, 15851837753@126.com
About this study
Official title: Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma
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)
- Being tested
- 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min, 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min
- Medical subject headings
- Melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10minDevice
5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins
10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10minOther
topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins
| Study group | Role | What they receive |
|---|---|---|
| Topical treatment with Ultrasound | Experimental | 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² for 10mins Receives: 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 Receives: Other: 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage reduction in hemi-MASI
mean percentage reduction in hemi-MASI from baseline to week 20
Measured: From enrollment to the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Secondary outcomes (4)
Patient self-assessment
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%
Measured: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Clinical Efficacy
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%.
Measured: week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
VISIA Digital Skin Analysis
Measured: 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
Measured: The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start20 Oct 2024
- Primary completion7 Feb 2026 (estimated)
- Study completion25 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melasma (Facial Melasma)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lu Yan, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202156
- Sponsor's protocol ID
- SR-820
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Efficacy and Safety of Ultrasound-Enhanced Delivery of Compound Tranexamic Acid Solution in the Treatment of Melasma
- ClinicalTrials.gov ID
- NCT07202156
- Acronym / sponsor ID
- SR-820
- Conditions
- Melasma (Facial Melasma)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 7 Feb 2026 (estimated)
- Study completion
- 25 Feb 2026 (estimated)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical treatment with Ultrasound | Experimental | Device: 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² for 10mins |
| Topical treatment without Ultrasound | Other | Other: 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² for 10mins |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -(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.
Key exclusion criteria (1 listed)
- (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min5w/cm² Ultrasound-assisted topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins | Device | Topical treatment with Ultrasound |
| 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10mintopical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins | Other | Topical treatment without Ultrasound |
Primary outcome
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
mean percentage reduction in hemi-MASI from baseline to week 20
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lu Yan, phD contact
Lu Yan study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 10%TXA+2%Reduced Glutathione applied via ultrasound at 5W/cm² in10min and 10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min in people with Melasma (Facial Melasma), run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Yan, phD (13913967126, luyan6289@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.