NCT07763262

Brief Summary

This randomized, split-site, within-participant controlled clinical study evaluated the efficacy and safety of a single session of autologous nanofat injection as an adjunct to narrowband ultraviolet B (NB-UVB) phototherapy in 20 adult patients with stable vitiligo. In each participant, one vitiligo site received autologous nanofat injection followed by NB-UVB phototherapy three times weekly for 3 months, while a comparable site received NB-UVB phototherapy alone. Treatment response was assessed by standardized photography performed by a blinded dermatologist, with evaluation of the onset and percentage of repigmentation, patient satisfaction, and treatment-related adverse effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

August 1, 2026

Enrollment Period

1.9 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Vitiligo Vulgaris

Keywords

vitiligo; Autologous nanofat; Nanofat injection; Narrowband ultraviolet B

Outcome Measures

Primary Outcomes (1)

  • Percentage of Repigmentation

    Percentage of repigmentation of the treated vitiligo site compared with baseline, assessed using standardized clinical and photographic evaluation and compared between the nanofat-treated site and the NB-UVB-only control site.

    Baseline to 3 months

Secondary Outcomes (3)

  • Onset of Repigmentation

    During the 3-month treatment period

  • Patient Satisfaction

    At the final 3-month assessment

  • Treatment-Related Adverse Effects

    From treatment initiation through 3 months

Study Arms (2)

Nanofat Injection + NB-UVB

EXPERIMENTAL

A single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion.

Procedure: Autologous Nanofat Injection

NB-UVB Alone

ACTIVE COMPARATOR

Narrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol.

Other: NB-UVB Phototherapy

Interventions

Autologous Nanofat InjectionPROCEDURE

A single session of autologous nanofat injection was performed in the randomly assigned vitiligo site. Nanofat was prepared from the participant's own adipose tissue according to the study protocol and injected into the selected vitiligo lesion.

Nanofat Injection + NB-UVB
NB-UVB PhototherapyOTHER

Narrowband ultraviolet B (NB-UVB) phototherapy was administered to both the nanofat-treated and control sites three times weekly for 3 months according to the study protocol.

NB-UVB Alone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Male or female patients.
  • Patients with clinically diagnosed stable vitiligo.
  • Presence of comparable vitiligo sites suitable for the split-site study design.
  • Ability to undergo autologous nanofat harvesting and injection.
  • Ability and willingness to undergo NB-UVB phototherapy three times weekly for 3 months.
  • Ability to comply with study follow-up and assessment procedures.
  • Provision of written informed consent.

You may not qualify if:

  • Active or progressive vitiligo.
  • Active infection or inflammation at the treatment sites.
  • Significant uncontrolled systemic disease that could interfere with treatment or assessment.
  • Contraindication to NB-UVB phototherapy.
  • Contraindication to the nanofat harvesting or injection procedure.
  • Previous treatment of the selected study sites that could interfere with assessment.
  • Inability to comply with the study protocol or follow-up.
  • Any condition considered by the investigator to interfere with the safety or assessment of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha faculty of medicine hospital

Banhā, Qaluybia, Egypt

Location

Related Publications (5)

  • Thind A, Vinay K, Mehta H, Bishnoi A, Kumaran MS, Parsad D. Whole-body and targeted narrowband ultraviolet B phototherapy effectively stabilize acral vitiligo with negligible repigmentation beyond wrists and ankles: Results from a split-body randomized controlled trial. Photodermatol Photoimmunol Photomed. 2024 Mar;40(2):e12960. doi: 10.1111/phpp.12960.

    PMID: 38480997RESULT

  • Asawanonda P, Klahan SO. Tetrahydrocurcuminoid cream plus targeted narrowband UVB phototherapy for vitiligo: a preliminary randomized controlled study. Photomed Laser Surg. 2010 Oct;28(5):679-84. doi: 10.1089/pho.2009.2637.

    PMID: 20961233RESULT

  • Esmat SM, El-Mofty M, Rasheed H, Mostafa WZ, Anbar TS, Abdallah M, Bassiouny D, Abdel-Halim D, Hegazy R, Eid AA, Nassar A, Abdel-Aziz RT, Fawzy MM, Gawdat HI, El Hawary M, Sany I, Shalaby S, Ragab N, Abdel-Gaber RM, Tawfik YM, El-Bassiouny M, El-Husseiny R, Attia MS, Farid C, Genedy RM, Mogawer RM. Efficacy of narrow band UVB with or without OMP in stabilization of vitiligo activity in skin photo-types (III-V): A double-blind, randomized, placebo-controlled, prospective, multicenter study. Photodermatol Photoimmunol Photomed. 2022 May;38(3):277-287. doi: 10.1111/phpp.12749. Epub 2021 Nov 18.

    PMID: 34726808RESULT

  • Middelkamp-Hup MA, Bos JD, Rius-Diaz F, Gonzalez S, Westerhof W. Treatment of vitiligo vulgaris with narrow-band UVB and oral Polypodium leucotomos extract: a randomized double-blind placebo-controlled study. J Eur Acad Dermatol Venereol. 2007 Aug;21(7):942-50. doi: 10.1111/j.1468-3083.2006.02132.x.

    PMID: 17659004RESULT

  • Tonnard P, Verpaele A, Peeters G, Hamdi M, Cornelissen M, Declercq H. Nanofat grafting: basic research and clinical applications. Plast Reconstr Surg. 2013 Oct;132(4):1017-1026. doi: 10.1097/PRS.0b013e31829fe1b0.

    PMID: 23783059RESULT

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The participants and treating investigator were not blinded to treatment allocation. The dermatologist responsible for evaluating the standardized clinical photographs and assessing repigmentation was blinded to the treatment allocation of the individual sites.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor Dermatology, Venereology and Andrology

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 13, 2026

Study Start

April 1, 2024

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

August 13, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)