Using shockwaves to deliver medication for treating melasma
Efficacy and Safety Trial of Using Ultra-Pulsed Shockwaves to Deliver Tranexamic Acid for the Treatment of Melasma
NA · Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT06418568
This study is testing if using shockwaves to deliver a medication can help treat melasma in Asian women of childbearing age.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06418568 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of using ultra-pulsed shockwave therapy to deliver tranexamic acid for the treatment of melasma, a common skin pigmentation disorder. The study will employ a non-randomized, self-half-face, pre-post controlled design to assess the depigmenting effects and safety profile of this innovative treatment approach. Participants will receive the treatment on one side of their face while the other side serves as a control. The trial aims to provide insights into a novel method for managing melasma, particularly in Asian women of childbearing age.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 18 and older diagnosed with melasma who can provide informed consent.
Not a fit: Patients with other pigmentary disorders, recent facial treatments, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new, effective option for patients suffering from melasma, potentially improving their skin appearance and quality of life.
How similar studies have performed: While there is limited research specifically on this approach, the use of shockwave therapy in dermatology has shown promise in other contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years, any gender; 2. Diagnosis of melasma; 3. Able to comprehend and voluntarily sign a written informed consent form, and able to complete the treatment and follow-up as required. Exclusion Criteria: 1. History of other pigmentary disorders such as lentigines, Ota nevus, freckles, etc.; 2. History of oral retinoid or tetracycline-class photosensitizing drugs within the past 6 months prior to treatment; 3. History of facial injections, fillers, chemical peels, laser or radiofrequency treatments, or other treatments targeting pigmentation within the past 6 months prior to treatment; 4. Abnormal coagulation function; 5. History of oral glucocorticoids or immunosuppressive agents within the past 3 months prior to treatment; 6. Patients with malignant tumors; 7. Pregnant or lactating women; 8. Patients with active herpes simplex or herpes zoster on the face.
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: SuiQing Cai, PHD
- Email: 2465598440@qq.com
- Phone: 13957107910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Chloasma