Melasma (Facial Melasma)
Conditions
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.
Interventions
DEVICE10%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
OTHER10%TXA+2%Reduced Glutathione applied via ultrasound at 0W/cm² 10min
topical application of 10% tranexamic acid and 2% reduced glutathione for 10 mins
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | This was to monitor experimental safety and the impact on the skin barrier. |
| Dermatoscopy | The enrollment, week 4 during treatment and the end of treatment at 8 weeks, and 4&12 weeks after the final intervention | — |
Countries
China
Contacts
Primary ContactLu Yan, phD
Backup ContactLu Yan, phD
Outcome results
None listed