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NCT06221787
Stem Cell Derived Exosomes in the Treatment of Melasma and Its Percutaneous Penetration
NA trial testing 1565 nm non-ablative fractional laser combined with normal saline in Melasma in 80 participants. Currently enrolling.
1 August 2025
Quick facts
| Lead sponsor | Fujian Medical University Union Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 April 2022 |
| Primary completion | 1 August 2025 |
| Estimated completion | 1 July 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- 1565 nm non-ablative fractional laser combined with normal saline
- microneedles combined with hUCMSC-Exos
- 1565 nm non-ablative fractional laser combined with hUCMSC-Exos
- PBASM combined with hUCMSC-Exos
Conditions studied
- Melasma — all drugs for Melasma →
Sponsor
Fujian Medical University Union Hospital
Who can join
Adults 18 to 60, any sex, with Melasma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Melasma is a refractory skin disease due to its complex pathogenesis and difficult treatment. Studies have found that human umbilical cord mesenchymal stem cell-derived exosomes (hUCMSC-Exos) could serve as a novel cell-free therapeutic strategy in regenerative and aesthetic medicine. It could potentially treat melasma, but the skin barrier is a challenge. This study aims to explore the safety and efficacy of hUCMSC-Exos in the treatment of melasma and means to promote its percutaneous penetration.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Insight into the Functional Dynamics and Challenges of Exosomes in Pharmaceutical Innovation and Precision Medicine.
Sharma A, Yadav A, Nandy A, Ghatak S. · · 2024 · cited 40× · PMID 38931833 · DOI 10.3390/pharmaceutics16060709 -
Standardized Reporting of Research on Exosomes to Ensure Rigor and Reproducibility.
Yadav A, Xuan Y, Sen CK, Ghatak S. · · 2024 · cited 28× · PMID 38888007 · DOI 10.1089/wound.2024.0093 -
Stem Cell-Based Acellular Therapy: Insight into Biogenesis, Bioengineering and Therapeutic Applications of Exosomes.
Choudhery MS, Arif T, Mahmood R, Harris DT. · · 2024 · cited 26× · PMID 39062506 · DOI 10.3390/biom14070792 -
From mechanism to applications: Advanced microneedles for clinical medicine.
Yang Y, Sun H, Sun X, Wang Y, et al · · 2025 · cited 9× · PMID 40463395 · DOI 10.1016/j.bioactmat.2025.04.025 -
Advancements in extracellular vesicles biomanufacturing: a comprehensive overview of large-scale production and clinical research.
Li Z, Yan J, Li X, Chen H, et al · · 2025 · cited 7× · PMID 40046812 · DOI 10.3389/fbioe.2025.1487627 -
The tiny giants of regeneration: MSC-derived extracellular vesicles as next-generation therapeutics.
Zhang T, Zhang L, Ma X, Song W. · · 2025 · cited 6× · PMID 40746857 · DOI 10.3389/fcell.2025.1612589 -
Extracellular vesicles and their mimetics: clinical application prospects in medical aesthetics.
Sun Z, Li J, Wu Z, Zhang J, et al · · 2025 · PMID 40757165 · DOI 10.1093/burnst/tkaf033
Verify or expand the search:
- PubMed search for NCT06221787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Melasma
Currently open trials in the same condition.
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- NCT07034560 — Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma · Phase 4 · active not recruiting
- NCT06516419 — Development of Products Based on Secretom From Stem Cell Conditioned Medium for Melasma Therapy · NA · recruiting
- NCT05942248 — The Use of Image-Based Computer Gradings in the Analysis of Acne, Rosacea, Melasma, and Seborrheic Dermatitis · NA · recruiting
Other Fujian Medical University Union Hospital trials
Trials by the same sponsor.
- NCT07406815 — The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Inva · Phase 3 · not yet recruiting
- NCT07444983 — Rezvilutamide for High-Risk Prostate Cancer After Surgery · NA · not yet recruiting
- NCT07493070 — Ultra-stable Iodized Oil-Chemo Embolization Seq Thermal Ablation in Early Liver Ca · NA · active not recruiting
- NCT07389889 — Percutaneous Robotic Navigation Microwave Ablation Versus CT-guided Microwave Ablation in the Treatment of Pulmonary Nod · NA · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06221787 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fujian Medical University Union Hospital
- Last refreshed: 2 July 2025
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