Comparative Efficacy of hUCMSC-Secretome Delivered Via Microneedling and Intradermal Microinjection as Adjuvant Therapy to NB-UVB in Nonsegmental Vitiligo: A Quasi-Experimental Study
Key facts
- Phase
- Phase 2/3
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07509242, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Yohanes Firmansyah, dr, MH, MM
- Trial code
- NCT07509242
- Record updated
- 3 April 2026
- Original description
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:Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; Segmental, universal, or other vitiligo types that are difficult to standardize (e.g., lesions limited to the genital area); Pregnancy or breastfeeding.