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

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Indonesia · 1 center

• Klinik Precious Me — Tangerang

Identifiers

NCT: NCT07509242 · 15.01.2026.15.04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗