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NOT YET RECRUITING
NCT07509242
PHASE2/PHASE3

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

Sponsor: Yohanes Firmansyah, dr, MH, MM

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-03-18

Completion Date

2028-01-18

Last Updated

2026-04-03

Healthy Volunteers

No

Conditions

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

Locations (1)

Klinik Precious Me

Tangerang, Banten, Indonesia