Status:
NOT_YET_RECRUITING
Combined Therapy of Photoelectric Instruments and Human Umbilical Cord Mesenchymal Stem Cells for Pigmentary Disorders
Lead Sponsor:
Shanghai East Hospital
Collaborating Sponsors:
ARSMO(Hainan) International Plastic & Aesthetic Hospital Company Limited
Conditions:
Mesenchymal Stem Cells；Pigmentary Disorders
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
Melasma is a common and refractory pigmentary skin disorder manifested as light to dark brown patches on the facial skin. It belongs to disfiguring dermatoses and significantly affects the physical an...
Eligibility Criteria
Inclusion
- Subjects must voluntarily participate in this study and sign a written informed consent form.
- Subjects are female patients with melasma aged between 18 and 60 years. Their diagnosis should conform to the "Chinese Expert Consensus on Diagnosis and Treatment of Melasma (2021 Edition)" formulated by the Pigmentary Disorders Subgroup of the Dermatovenereology Committee of the China Association of Integrative Medicine. The skin lesions manifest as light brown or dark brown patches of varying depths and with indistinct borders on the cheeks, forehead, and jaw. Subjects must be excluded from having post-inflammatory hyperpigmentation, naevus of Ota, Riehl's melanosis, pigmented lichen planus, and other skin diseases. Additionally, their melasma should have been in a stable phase for 3 months or more.
- Subjects have never undergone stem cell therapy or laser treatment for melasma.
Exclusion
- Subjects with a history of photosensitivity or allergies to biological medications.
- Subjects who are pregnant or lactating.
- Subjects who have a history of alcohol abuse, drug addiction, or substance abuse in the past 24 months.
- Subjects with concurrent severe systemic diseases, malignancies, or psychiatric disorders.
- Subjects with active infections, including bacterial, fungal, and viral infections.
- Subjects with keloid constitution.
- Subjects with a history of severe sun exposure within 4 weeks before enrollment.
- Subjects deemed unsuitable for enrollment by the investigator for various reasons or any other conditions that the investigator believes may compromise the safety or compliance of the subject or hinder the successful completion of the study.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06911281
Start Date
June 1 2025
End Date
December 31 2027
Last Update
April 4 2025
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