Possible Augmentation Of NB-UVB Induced Pigmentation In NSV By Carboxy. (NB-UVB)

April 25, 2026 updated by: Rana F Hilal, MD, Kasr El Aini Hospital

Evaluation Of Carboxytherapy As An Adjuvant To Narrowband-Ultraviolet B Phototherapy For The Treatment Of Stable Non-Segmental Vitiligo: A Clinical And Biochemical Study .

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El Manial
      • Cairo, El Manial, Egypt, 11956
        • Faculty of Medicine, Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: NB-UVB
Device: NB-UVB alone
Narrow-Band Ultraviolet B phototherapy full cabin
Active Comparator: NB-UVB combined with carboxy
Device: NB-UVB combined with carboxy
Narrow-Band Ultraviolet B phototherapy full cabin combined with Intradermal injection of carbon dioxide gas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vitiligo Extent Score for a Target Area (VESTA)
Time Frame: 6 months- 1 year
Assessment of the treatment response in a target area Range 0-100%
6 months- 1 year
Estimation of human E-Cadherin using ELISA
Time Frame: 6 months -1 year
6 months -1 year
Estimation of malondialdehyde by spectrophotometer
Time Frame: 6 months-1 year
6 months-1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' global satisfaction
Time Frame: 6 months -1 year

five-point grading scale

-1-3
6 months -1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2024

Primary Completion (Actual)

December 22, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 25, 2026

First Submitted That Met QC Criteria

April 25, 2026

First Posted (Actual)

May 1, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 25, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VitCarboxy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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