Comparative Efficacy of hUCMSC-Secretome Delivered Via Microneedling and Intradermal Microinjection as Adjuvant Therapy to NB-UVB in Nonsegmental Vitiligo: A Quasi-Experimental Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage of Patients Achieving ≥50% Repigmentation Assessed by Vitiligo Area Scoring Index (VASI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group A
receives NB-UVB combined with microneedling and topical 10% secretome
干预措施: NB-UVB combined with microneedling and topical 10% secretome (Other)
Group B
receives NB-UVB combined with intradermal secretome injection.
干预措施: receives NB-UVB combined with intradermal secretome injection (Other)
Group C
receives NB-UVB alone.
干预措施: NB-UVB alone (Drug)
结局指标
主要结局
Percentage of Patients Achieving ≥50% Repigmentation Assessed by Vitiligo Area Scoring Index (VASI)
时间窗: Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up)
The primary outcome is the proportion of patients achieving at least 50% repigmentation of target vitiligo lesions, measured using the Vitiligo Area Scoring Index (VASI). Repigmentation will be calculated as the percentage reduction in depigmented area compared to baseline. Assessment will be performed by blinded dermatologists using standardized clinical evaluation and validated scoring methods.
次要结局
- Change in VASI Score from Baseline(Baseline, Week 4, Week 8, Week 12, Week 24)
- Time to Onset of Repigmentation(Up to Week 12)
- Change in Dermatology Life Quality Index (DLQI) Score(Baseline, Week 12, Week 24)
- Patient Satisfaction Measured by Likert Scale(Week 12 and Week 24)
- Patient Global Assessment (PGA) Score(Week 12 and Week 24)
研究者
Yohanes Firmansyah, dr, MH, MM
Clinical officer
Tarumanagara University