NCT07509242

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

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Yohanes Firmansyah, dr, MH, MM · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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. 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.

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

Interventions

Type	Name	Description
OTHER	NB-UVB combined with microneedling and topical 10% secretome	Group A receives NB-UVB combined with microneedling and topical 10% secretome.
OTHER	receives NB-UVB combined with intradermal secretome injection	Group B receives NB-UVB combined with intradermal secretome injection
DRUG	NB-UVB alone	Group C receives NB-UVB alone

Timeline

• Start date: 2026-03-18
• Primary completion: 2027-01-18
• Completion: 2028-01-18
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Indonesia