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.
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).
Segmental, universal, or other vitiligo types that are difficult to standardize (e.g., lesions limited to the genital area).
Systemic immunomodulatory or immunosuppressive therapy (e.g., systemic corticosteroids, cyclosporine, methotrexate, JAK inhibitors, etc.).
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.
Parallel
NB-UVB combined with microneedling and topical 10% secretome
Other interventionGroup A receives NB-UVB combined with microneedling and topical 10% secretome.
receives NB-UVB combined with intradermal secretome injection
Other interventionGroup B receives NB-UVB combined with intradermal secretome injection
NB-UVB alone
DrugGroup C receives NB-UVB alone
Percentage of Patients Achieving ≥50% Repigmentation Assessed by Vitiligo Area Scoring Index (VASI)
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.
Change in VASI Score from Baseline
The absolute change in VASI score (points) from baseline to each follow-up visit will be evaluated. VASI quantifies both the extent of vitiligo involvement and degree of depigmentation. Lower scores indicate clinical improvement.
Time to Onset of Repigmentation
Time (in weeks) from initiation of treatment to the first clinically observable repigmentation (≥10% repigmentation or perifollicular repigmentation), assessed by dermatologists based on clinical examination and standardized dermatological photography.
Change in Dermatology Life Quality Index (DLQI) Score
Quality of life will be assessed using the Dermatology Life Quality Index (DLQI) questionnaire. The outcome will be expressed as the change in DLQI score (points) from baseline, with lower scores indicating improved quality of life.
Patient Satisfaction Measured by Likert Scale
Patient satisfaction will be assessed using a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied). The outcome will be reported as mean satisfaction score.
Incidence of Adverse Events
The proportion (%) of patients experiencing local or systemic adverse events related to treatment will be recorded. Adverse events include erythema, pain, edema, infection, post-inflammatory hyperpigmentation, and other complications. Severity will be classified as mild, moderate, or severe.
Recurrence Rate of Vitiligo
The proportion (%) of patients experiencing recurrence, defined as ≥25% loss of previously repigmented area or development of new depigmented lesions, assessed using VASI and standardized dermatological photography.
Repigmentation Assessed by Standardized Dermatological Photography
Repigmentation will be evaluated using standardized dermatological photography with controlled lighting, positioning, and calibration. Images will be assessed by blinded dermatologists to estimate percentage of repigmentation (%), ensuring objective visual documentation.
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Yohanes Firmansyah, dr, MH, MM
Lead sponsor
Tarumanagara University
Sponsor institution
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