A Phase 2/3 interventional study of NB-UVB combined with microneedling and topical 10% secretome and receives NB-UVB combined with intradermal secretome injection in Vitiligo, sponsored by Yohanes Firmansyah, dr, MH, MM. Not yet recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Yohanes Firmansyah, dr, MH, MM · Phase 2/3, Interventional, and Treatment
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:
Participants will be allocated into three groups as follows:
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.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 150 is above the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Yohanes Firmansyah, dr, MH, MM is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other phototherapy modalities (e.g., PUVA, excimer laser) within the past 3 months.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
receives NB-UVB combined with microneedling and topical 10% secretome
Other: NB-UVB combined with microneedling and topical 10% secretome
receives NB-UVB combined with intradermal secretome injection.
Other: receives NB-UVB combined with intradermal secretome injection
receives NB-UVB alone.
Drug: NB-UVB alone
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
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.
Time frame: Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up)
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 frame: Baseline, Week 4, Week 8, Week 12, Week 24
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.
Time frame: Up to Week 12
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.
Time frame: Baseline, Week 12, Week 24
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.
Time frame: Week 12 and Week 24
Patient Global Assessment (PGA) Score
Clinical improvement as perceived by patients will be evaluated using the Patient Global Assessment (PGA) scale (0-4), where higher scores indicate greater perceived improvement.
Time frame: Week 12 and Week 24
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.
Time frame: From baseline to Week 12
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.
Time frame: Week 24
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.
Time frame: Baseline, Week 4, Week 8, Week 12, Week 24
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Yohanes Firmansyah, dr, MH, MM