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

NCT07509242 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-04-03

No results posted yet for this study

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.

Conditions

  • Vitiligo

Interventions

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

Sponsors & Collaborators

  • Yohanes Firmansyah, dr, MH, MM

    lead OTHER

Principal Investigators

  • Sukmawati Tansil Tan · Tarumanagara University

  • Yohanes Firmansyah · Universitas Tarumanagara

  • Michael Jansen Politan · Precious Me Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2027-01-18
Completion
2028-01-18

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07509242 on ClinicalTrials.gov