Trials Sponsors Conditions Drugs Pricing

Conditions

Vitiligo

Keywords

DermatologyMicroneedlingNB-UVBSecretomeVitiligo

Outcome Measures

Primary Outcomes (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.
Baseline, Week 4, Week 8, Week 12 (primary endpoint), and Week 24 (follow-up)

Secondary Outcomes (5)

Change in VASI Score from Baseline
Baseline, Week 4, Week 8, Week 12, Week 24
Time to Onset of Repigmentation
Up to Week 12
Change in Dermatology Life Quality Index (DLQI) Score
Baseline, Week 12, Week 24
Patient Satisfaction Measured by Likert Scale
Week 12 and Week 24
Patient Global Assessment (PGA) Score
Week 12 and Week 24

Other Outcomes (3)

Incidence of Adverse Events
From baseline to Week 12
Recurrence Rate of Vitiligo
Week 24
Repigmentation Assessed by Standardized Dermatological Photography
Baseline, Week 4, Week 8, Week 12, Week 24

Study Arms (3)

Group A

EXPERIMENTAL

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

Other: NB-UVB combined with microneedling and topical 10% secretome

Group B

EXPERIMENTAL

receives NB-UVB combined with intradermal secretome injection.

Other: receives NB-UVB combined with intradermal secretome injection

Group C

EXPERIMENTAL

receives NB-UVB alone.

Drug: NB-UVB alone

Interventions

NB-UVB combined with microneedling and topical 10% secretomeOther

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

Group A

receives NB-UVB combined with intradermal secretome injectionOther

Group B receives NB-UVB combined with intradermal secretome injection

Group B

Eligibility Criteria

Age18 Years - 60 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Patients with a diagnosis of non-segmental vitiligo (established by a dermatologist).
Age 18-60 years.

Sponsors & Collaborators

Yohanes Firmansyah, dr, MH, MM
Otherlead

Study Sites (1)

Klinik Precious Me

Tangerang, Banten, 11440, Indonesia

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

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

Sukmawati Tansil TanPRINCIPAL INVESTIGATOR

YohaneS FirmansyahSUB INVESTIGATOR

MeSH Terms

Conditions

Vitiligo

Interventions

Percutaneous Collagen InductionSecretome

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesPuncturesRehabilitation

Study Officials

Sukmawati Tansil Tan
Tarumanagara University
PRINCIPAL INVESTIGATOR
Yohanes Firmansyah
Universitas Tarumanagara
STUDY DIRECTOR
Michael Jansen Politan
Precious Me Clinic
STUDY CHAIR

Central Study Contacts

Sukmawati Tansil Tan, Dr.

CONTACT

+6287871111318 sukmawati@fk.untar.ac.id

Yohanes Firmansyah, MD

CONTACT

+6281297934375

Study Design

Study Type: interventional
Phase: phase 2 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Clinical officer

Study Record Dates

First Submitted

March 13, 2026

First Posted

April 3, 2026

Study Start

March 18, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

January 18, 2027

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (3)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Other Outcomes (3)

Study Arms (3)

Group A

Group B

Group C

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations