Comparative Efficacy of hUCMSC-Secretome Delivered Via Microneedling and Intradermal Microinjection as Adjuvant Therapy to NB-UVB in Nonsegmental Vitiligo: A Quasi-Experimental Study

Обзор

The goal of this clinical trial is to analyze the effectiveness of SM-hUCMSC secretome administered via microneedling and intradermal microinjection as adjuvant therapy to NB-UVB, compared with NB-UVB alone, in terms of repigmentation, onset of improvement, safety, patient satisfaction, and vitiligo recurrence. The main questions it aims to answer are: * Are there differences in the level of vitiligo lesion repigmentation among the secretome therapy via microneedling, intradermal microinjection, and NB-UVB phototherapy groups? * Are there differences in the time to onset of repigmentation among the treatment groups? What are the safety profiles and adverse events associated with each treatment modality? * Are there differences in patient satisfaction and quality of life after undergoing each therapy? * Are there differences in vitiligo recurrence rates during the follow-up period among the treatment groups? Participants will be allocated into three groups as follows: * Group A receives NB-UVB combined with microneedling and topical 10% secretome. * Group B receives NB-UVB combined with intradermal secretome injection. * Group C receives NB-UVB alone. The intervention period lasts 12 weeks, with follow-up until week 24.

Подробное описание

This study aims to analyze the effectiveness of SM-hUCMSC secretome administered via microneedling and intradermal microinjection as adjuvant therapy to NB-UVB, compared with NB-UVB alone, in terms of repigmentation, onset of improvement, safety, patient satisfaction, and vitiligo recurrence.

This quasi-experimental three-group study involves patients with nonsegmental vitiligo who meet the inclusion criteria at the Precious Me Clinic, Serpong.

* Group A receives NB-UVB combined with microneedling and topical 10% secretome. * Group B receives NB-UVB combined with intradermal secretome injection. * Group C receives NB-UVB alone. The intervention lasts for 12 weeks with follow-up until week 24. Assessments are conducted using the Vitiligo Area Scoring Index (VASI), onset of repigmentation, Dermatology Life Quality Index (DLQI), Patient Global Assessment, adverse event monitoring, and standardized dermatologic photographic documentation. Data analysis is performed using ANOVA or Kruskal-Wallis tests, Kaplan-Meier survival analysis, and proportion tests as appropriate.

Вмешательства

• Другое NB-UVB combined with microneedling and topical 10% secretome
  Group A receives NB-UVB combined with microneedling and topical 10% secretome.
• Другое receives NB-UVB combined with intradermal secretome injection
  Group B receives NB-UVB combined with intradermal secretome injection
• Препарат NB-UVB alone
  Group C receives NB-UVB alone

Первичные конечные точки

• Percentage of Patients Achieving ≥50% Repigmentation Assessed by Vitiligo Area Scoring Index (VASI) [Срок оценки: Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up)]

Вторичные конечные точки (5)

• Change in VASI Score from Baseline [Срок оценки: Baseline, Week 4, Week 8, Week 12, Week 24]
• Time to Onset of Repigmentation [Срок оценки: Up to Week 12]
• Change in Dermatology Life Quality Index (DLQI) Score [Срок оценки: Baseline, Week 12, Week 24]
• Patient Satisfaction Measured by Likert Scale [Срок оценки: Week 12 and Week 24]
• Patient Global Assessment (PGA) Score [Срок оценки: Week 12 and Week 24]

Критерии участия

Критерии включения

• Patients with a diagnosis of non-segmental vitiligo (established by a dermatologist).
• Age 18-60 years.
• Fitzpatrick skin types III-V.
• Stable vitiligo lesions for at least 6 months (no new lesions and no lesion expansion >10% of body surface area within the past 6 months).
• Total lesion involvement of 1-20% body surface area (BSA).
• Willing to comply with the full course of therapy and all scheduled follow-up visits during the study.
• Provision of written informed consent.

Критерии исключения

• Segmental, universal, or other vitiligo types that are difficult to standardize (e.g., lesions limited to the genital area).
• Currently receiving or having received within the past 3 months:
• Systemic immunomodulatory or immunosuppressive therapy (e.g., systemic corticosteroids, cyclosporine, methotrexate, JAK inhibitors, etc.).

Other phototherapy modalities (e.g., PUVA, excimer laser) within the past 3 months.

• History of keloid formation or hypertrophic scarring at the treatment sites.
• Active infection at the lesion sites (bacterial, viral, or fungal) or other skin diseases that may interfere with pigmentation assessment.
• Pregnancy or breastfeeding.
• History of skin cancer, lupus, or other photosensitive disorders.
• Severe allergy to secretome components or gel excipients (if known).
• Uncontrolled systemic diseases (e.g., heart failure, renal failure, active systemic autoimmune disease) that may compromise follow-up compliance.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Klinik Precious Me — Tangerang

Идентификаторы

NCT: NCT07509242 · 15.01.2026.15.04

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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