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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Vitiligo
• Intervention / Treatment: Other: NB-UVB combined with microneedling and topical 10% secretome; Other: receives NB-UVB combined with intradermal secretome injection; Drug: NB-UVB alone

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Yohanes Firmansyah, MD; Phone Number: +6281297934375; Email: yohanes@fk.untar.ac.id
• Study Contact Backup: Name: Sukmawati Tansil Tan, Dr.; Phone Number: +6287871111318; Email: sukmawati@fk.untar.ac.id

Study Locations

• Indonesia
  • Banten
    • Tangerang, Banten, Indonesia, 11440
      • Klinik Precious Me
      • Contact: Yohanes Firmansyah, MD; Phone Number: +6281297934375; Email: yohanes@fk.untar.ac.id
      • Contact: Sukmawati Tansil Tan, Dr.; Phone Number: +6287871111318; Email: sukmawati@fk.untar.ac.id
      • Principal Investigator: Sukmawati Tansil Tan
      • Sub-Investigator: YohaneS Firmansyah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; receives NB-UVB combined with microneedling and topical 10% secretome	Other: NB-UVB combined with microneedling and topical 10% secretome; Group A receives NB-UVB combined with microneedling and topical 10% secretome.
Experimental: Group B; receives NB-UVB combined with intradermal secretome injection.	Other: receives NB-UVB combined with intradermal secretome injection; Group B receives NB-UVB combined with intradermal secretome injection
Experimental: Group C; receives NB-UVB alone.	Drug: NB-UVB alone; Group C receives NB-UVB alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	Week 12 and Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline, Week 4, Week 8, Week 12, Week 24

Collaborators and Investigators

• Sponsor: Yohanes Firmansyah, dr, MH, MM
• Investigators: Principal Investigator: Sukmawati Tansil Tan, Tarumanagara University; Study Director: Yohanes Firmansyah, Universitas Tarumanagara; Study Chair: Michael Jansen Politan, Precious Me Clinic

Study record dates

Study Major Dates

• Study Start (Estimated): March 18, 2026
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): January 18, 2028

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 28, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 28, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Dermatology; Microneedling; Secretome; Vitiligo; NB-UVB
• Additional Relevant MeSH Terms: Skin Diseases; Hypopigmentation; Pigmentation Disorders; Skin and Connective Tissue Diseases; Vitiligo; Therapeutics; Punctures; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Metabolism; Metabolome; Percutaneous Collagen Induction; Secretome
• Other Study ID Numbers: 15.01.2026.15.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No