NCT07563049

Brief Summary

Patients with stable vitiligo with 2 or more symmetric patches, 2 on acral sites and/or 2 on non acral sites will be recruited and assessed for eligibility for inclusion to receive NB-UVB on the whole body, and carboxytherapy on one randomized side.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for phase_4

Timeline
1mo left

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress96%
Sep 2024Jun 2026

Study Start

First participant enrolled

September 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

1.3 years

First QC Date

April 25, 2026

Last Update Submit

April 25, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Vitiligo Extent Score for a Target Area (VESTA)

    Assessment of the treatment response in a target area Range 0-100%

    6 months- 1 year

  • Estimation of human E-Cadherin using ELISA

    6 months -1 year

  • Estimation of malondialdehyde by spectrophotometer

    6 months-1 year

Secondary Outcomes (1)

  • Patients' global satisfaction

    6 months -1 year

Study Arms (2)

NB-UVB

PLACEBO COMPARATOR
Device: NB-UVB alone

NB-UVB combined with carboxy

ACTIVE COMPARATOR
Device: NB-UVB combined with carboxy

Interventions

Narrow-Band Ultraviolet B phototherapy full cabin

NB-UVB

Narrow-Band Ultraviolet B phototherapy full cabin combined with Intradermal injection of carbon dioxide gas

NB-UVB combined with carboxy

Eligibility Criteria

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

You may qualify if:

  • Subjects with stable non-segmental vitiligo (≥2 symmetrical patches of diameter less than 2 cm on acral or ≥ 2 symmetrical patches on non-acral sites). Subjects were stable for twelve or more months.

You may not qualify if:

  • Subjects with unstable vitiligo.
  • Subjects with segmental vitiligo.
  • Pregnant females.
  • Severe anemia (Hb \<7 gm/dl).
  • Cardiac/hepatic/renal/respiratory failure.
  • Superficial thrombophlebitis.
  • Subjects with history of skin malignancy or precancerous conditions like Xeroderma pigmentosum.
  • Subjects with other autoimmune disorders.
  • Systemic drugs for vitiligo in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, El Manial, 11956, Egypt

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 1, 2026

Study Start

September 15, 2024

Primary Completion

December 22, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations