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VitiligoPhase 2/3VitiligoNCT07509242

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

A Phase 2/3 study testing NB-UVB combined with microneedling and topical 10% secretome, receives NB-UVB combined with intradermal secretome injection and NB-UVB alone in people with Vitiligo, run by Yohanes Firmansyah, dr, MH, MM at 1 site in Indonesia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Vitiligo
What is being tested?
NB-UVB combined with microneedling and topical 10% secretome, receives NB-UVB combined with intradermal secretome injection and NB-UVB alone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIndonesia
Study dates
18 Mar 2026to 18 Jan 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sukmawati Tansil Tan, Dr. contact

+6287871111318

sukmawati@fk.untar.ac.id

Yohanes Firmansyah, MD contact

+6281297934375

yohanes@fk.untar.ac.id

Indonesia1 site

  • Klinik Precious Me

    Tangerang, Banten, 11440

    Sukmawati Tansil Tan, Dr., +6287871111318, sukmawati@fk.untar.ac.id

    Yohanes Firmansyah, MD, +6281297934375, yohanes@fk.untar.ac.id

Other trials in Indonesia

About this study

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?
Read more

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.
Read the 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.
Conditions
Vitiligo
Being tested
NB-UVB combined with microneedling and topical 10% secretome, receives NB-UVB combined with intradermal secretome injection, NB-UVB alone
Keywords
Dermatology, Microneedling, NB-UVB, Secretome, Vitiligo
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NB-UVB combined with microneedling and topical 10% secretomeOther

    Group A receives NB-UVB combined with microneedling and topical 10% secretome.

  • receives NB-UVB combined with intradermal secretome injectionOther

    Group B receives NB-UVB combined with intradermal secretome injection

  • NB-UVB aloneDrug

    Group C receives NB-UVB alone

Study groups in NCT07509242
Study groupRoleWhat they receive
Group AExperimentalreceives NB-UVB combined with microneedling and topical 10% secretome
Receives: Other: NB-UVB combined with microneedling and topical 10% secretome
Group BExperimentalreceives NB-UVB combined with intradermal secretome injection.
Receives: Other: receives NB-UVB combined with intradermal secretome injection
Group CExperimentalreceives NB-UVB alone.
Receives: Drug: NB-UVB alone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (5)

  1. 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.

    Measured: Baseline, Week 4, Week 8, Week 12, Week 24

  2. 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.

    Measured: Up to Week 12

  3. 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.

    Measured: Baseline, Week 12, Week 24

  4. 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.

    Measured: Week 12 and Week 24

  5. 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.

    Measured: Week 12 and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2026
  2. Study start18 Mar 2026 (estimated)
  3. Primary completion18 Jan 2027 (estimated)
  4. Study completion18 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07509242
Sponsor's protocol ID
15.01.2026.15.04
Acronym
Vitiligo
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing NB-UVB combined with microneedling and topical 10% secretome, receives NB-UVB combined with intradermal secretome injection and NB-UVB alone in people with Vitiligo, run by Yohanes Firmansyah, dr, MH, MM at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sukmawati Tansil Tan, Dr. (+6287871111318, sukmawati@fk.untar.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07509242.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.

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