Not Yet RecruitingPhase 2/3

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

Indonesia150 participantsStarted 2026-03-18

Plain-language summary

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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Patients Achieving ≥50% Repigmentation Assessed by Vitiligo Area Scoring Index (VASI)

Timeframe: Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up)

Trial details

NCT IDNCT07509242

SponsorYohanes Firmansyah, dr, MH, MM

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01-18

Contact for this trial

Sukmawati Tansil Tan, Dr.

+6287871111318 sukmawati@fk.untar.ac.id

View on ClinicalTrials.gov More Vitiligo trials